Method and apparatus for penetrating tissue

ABSTRACT

A skin penetrating system has a housing member and a plurality of penetrating members positioned in the housing member. A tissue stabilizing device is coupled to the housing member. A user interface is configured to relay at least one of, skin penetrating performance or a skin penetrating setting.

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application is a continuation-in-part of commonly assigned,copending U.S. patent application Ser. No. 10/127,395 (Attorney DocketNo. 38187-2551) filed Apr. 19, 2002. This application also claims thebenefit of priority from commonly assigned, copending U.S. patentapplication Ser. No. 10/237,261 (Attorney Docket No. 38187-2595) filedSep. 5, 2002 and commonly assigned, copending U.S. patent applicationSer. No. ______ (Attorney Docket No. 38187-2592) filed Sep. 5, 2002. Allapplications listed above are fully incorporated herein by reference forall purposes.

BACKGROUND OF THE INVENTION

[0002] Lancing devices are known in the medical health-care productsindustry for piercing the skin to produce blood for analysis. Typically,a drop of blood for this type of analysis is obtained by making a smallincision in the fingertip, creating a small wound, which generates asmall blood droplet on the surface of the skin.

[0003] Early methods of lancing included piercing or slicing the skinwith a needle or razor. Current methods utilize lancing devices thatcontain a multitude of spring, cam and mass actuators to drive thelancet. These include cantilever springs, diaphragms, coil springs, aswell as gravity plumbs used to drive the lancet. The device may be heldagainst the skin and mechanically triggered to ballistically launch thelancet. Unfortunately, the pain associated with each lancing event usingknown technology discourages patients from testing. In addition tovibratory stimulation of the skin as the driver impacts the end of alauncher stop, known spring based devices have the possibility ofharmonically oscillating against the patient tissue, causing multiplestrikes due to recoil. This recoil and multiple strikes of the lancetagainst the patient is one major impediment to patient compliance with astructured glucose monitoring regime.

[0004] Another impediment to patient compliance is the lack ofspontaneous blood flow generated by known lancing technology. Inaddition to the pain as discussed above, a patient may need more thanone lancing event to obtain a blood sample since spontaneous bloodgeneration is unreliable using known lancing technology. Thus the painis multiplied by the number of tries it takes to successfully generatespontaneous blood flow. Different skin thickness may yield differentresults in terms of pain perception, blood yield and success rate ofobtaining blood between different users of the lancing device. Knowndevices poorly account for these skin thickness variations.

[0005] A still further impediment to improved compliance with glucosemonitoring are the many steps and hassle associated with each lancingevent. Many diabetic patients that are insulin dependent may need toself-test for blood glucose levels five to six times daily. The largenumber of steps required in traditional methods of glucose testing,ranging from lancing, to milking of blood, applying blood to the teststrip, and getting the measurements from the test strip, discouragesmany diabetic patients from testing their blood glucose levels as oftenas recommended. Older patients and those with deteriorating motor skillsencounter difficulty loading lancets into launcher devices, transferringblood onto a test strip, or inserting thin test strips into slots onglucose measurement meters. Additionally, the wound channel left on thepatient by known systems may also be of a size that discourages thosewho are active with their hands or who are worried about healing ofthose wound channels from testing their glucose levels.

SUMMARY OF THE INVENTION

[0006] Accordingly, an object of the present invention is to provideimproved tissue penetrating systems, and their methods of use.

[0007] Another object of the present invention is to provide tissuepenetrating systems, and their methods of use, that provide reduced painwhen penetrating a target tissue.

[0008] Yet another object of the present invention is to provide tissuepenetrating systems, and their methods of use, that provide controlleddepth of penetration.

[0009] Still a further object of the present invention is to providetissue penetrating systems, and their methods of use, that providecontrolled velocities into and out of target tissue.

[0010] A further object of the present invention is to provide tissuepenetrating systems, and their methods of use, that provide stimulationto a target tissue.

[0011] Another object of the present invention is to provide tissuepenetrating systems, and their methods of use, that apply a pressure toa target tissue.

[0012] Yet another object of the present invention is to provide tissuepenetrating systems, and their methods of use, with penetrating membersthat remain in sterile environments prior to launch.

[0013] Still another object of the present invention is to providetissue penetrating systems, and their methods of use, with penetratingmembers that remain in sterile environments prior to launch, and thepenetrating members are not used to breach the sterile environment.

[0014] A further object of the present invention is to provide improvedtissue penetrating systems, and their methods of use, that have userinterfaces.

[0015] Another object of the present invention is to provide improvedtissue penetrating systems, and their methods of use, that have humaninterfaces.

[0016] Yet another object of the present invention is to provide tissuepenetrating systems, and their methods of use, that have low volumesample chambers.

[0017] Still another object of the present invention is to providetissue penetrating systems, and their methods of use, that have samplechambers with volumes that do not exceed 1 μL.

[0018] Another object of the present invention is to provide tissuepenetrating systems, and their methods of use, that have multiplepenetrating members housed in a cartridge.

[0019] These and other objects of the present invention are achieved ina skin penetrating system, with a housing member and a plurality ofpenetrating members positioned in the housing member. A tissuestabilizing device is coupled to the housing member. A user interface isconfigured to relay at least one of, skin penetrating performance or askin penetrating setting.

[0020] In another embodiment of the present invention, a tissuepenetrating system includes a housing and at least one penetratingmember. A penetrating member driver is coupled to the at least onepenetrating member. A tissue stabilizer member is coupled to thehousing. A human interface provides at least one output.

[0021] A further understanding of the nature and advantages of theinvention will become apparent by reference to the remaining portions ofthe specification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022]FIG. 1 illustrates an embodiment of a controllable force driver inthe form of a cylindrical electric penetrating member driver using acoiled solenoid type configuration.

[0023]FIG. 2A illustrates a displacement over time profile of apenetrating member driven by a harmonic spring/mass system.

[0024]FIG. 2B illustrates the velocity over time profile of apenetrating member driver by a harmonic spring/mass system.

[0025]FIG. 2C illustrates a displacement over time profile of anembodiment of a controllable force driver.

[0026]FIG. 2D illustrates a velocity over time profile of an embodimentof a controllable force driver.

[0027]FIG. 3 is a diagrammatic view illustrating a controlled feed-backloop.

[0028]FIG. 4 is a perspective view of a tissue penetration device havingfeatures of the invention.

[0029]FIG. 5 is an elevation view in partial longitudinal section of thetissue penetration device of FIG. 4.

[0030] FIGS. 6A-6C show a flowchart illustrating a penetrating membercontrol method.

[0031]FIG. 7 is a diagrammatic view of a patient's finger and apenetrating member tip moving toward the skin of the finger.

[0032]FIG. 8 is a diagrammatic view of a patient's finger and thepenetrating member tip making contact with the skin of a patient'sfinger.

[0033]FIG. 9 is a diagrammatic view of the penetrating member tipdepressing the skin of a patient's finger.

[0034]FIG. 10 is a diagrammatic view of the penetrating member tipfurther depressing the skin of a patient's finger.

[0035]FIG. 11 is a diagrammatic view of the penetrating member tippenetrating the skin of a patient's finger.

[0036]FIG. 12 is a diagrammatic view of the penetrating member tippenetrating the skin of a patient's finger to a desired depth.

[0037]FIG. 13 is a diagrammatic view of the penetrating member tipwithdrawing from the skin of a patient's finger.

[0038] FIGS. 14-18 illustrate a method of tissue penetration that maymeasure elastic recoil of the skin.

[0039]FIG. 19 is a perspective view in partial section of a tissuepenetration sampling device with a cartridge of sampling modules.

[0040]FIG. 20 is a perspective view of a sampling module cartridge withthe sampling modules arranged in a ring configuration.

[0041]FIG. 21 illustrate an embodiment of a cartridge for use insampling having a sampling cartridge body and a penetrating membercartridge body.

[0042]FIG. 22A shows a device for use on a tissue site having aplurality of penetrating members.

[0043]FIG. 22B shows rear view of a device for use on a tissue sitehaving a plurality of penetrating members.

[0044]FIG. 22C shows a schematic of a device for use on a tissue sitewith a feedback loop and optionally a damper.

[0045]FIG. 23A shows an embodiment of a device with a user interface.

[0046]FIG. 23B shows an outer view of a device with a user interface.

[0047]FIG. 24 is a cut away view of a system for sampling body fluid.

[0048]FIG. 25 is an exploded view of a cartridge for use with a systemfor sampling body fluid.

[0049]FIG. 26 is an exploded view of a cartridge having multiplepenetrating members for use with a system for sampling body fluid.

[0050] FIGS. 27-28 show cartridges for use with a system for samplingbody fluid.

[0051]FIG. 29 shows a cutaway view of another embodiment of a system forsampling body fluid.

[0052]FIG. 30 shows the density associated with a cartridge according tothe present invention.

[0053]FIG. 31 shows a cutaway view of another embodiment of a system forsampling body fluid.

[0054]FIG. 32 is a cut away view of a cartridge according to the presentinvention.

[0055] FIGS. 33-34 show views of a body sampling system using multiplecartridges.

[0056]FIG. 35 shows an embodiment of the present invention with a tissuestabilizing member.

[0057]FIG. 36 shows a cartridge according to the present invention witha tissue stabilizing member.

[0058]FIG. 37 shows a system according to the present invention with amoveable cartridge.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

[0059] The present invention provides a solution for body fluidsampling. Specifically, some embodiments of the present inventionprovides a penetrating member device for consistently creating a woundwith spontaneous body fluid flow from a patient. The invention may be amultiple penetrating member device with an optional high density design.It may use penetrating members of smaller size than known penetratingmembers. The device may be used for multiple lancing events withouthaving to remove a disposable from the device or for the user to handlesharps. The invention may provide improved sensing capabilities. Atleast some of these and other objectives described herein will be met byembodiments of the present invention.

[0060] It is to be understood that both the foregoing generaldescription and the following detailed description are exemplary andexplanatory only and are not restrictive of the invention, as claimed.It should be noted that, as used in the specification and the appendedclaims, the singular forms “a”, “an” and “the” include plural referentsunless the context clearly dictates otherwise. Thus, for example,reference to “a material” may include mixtures of materials, referenceto “a chamber” may include multiple chambers, and the like. Referencescited herein are hereby incorporated by reference in their entirety,except to the extent that they conflict with teachings explicitly setforth in this specification.

[0061] In this specification and in the claims which follow, referencewill be made to a number of terms which shall be defined to have thefollowing meanings:

[0062] “Optional” or “optionally” means that the subsequently describedcircumstance may or may not occur, so that the description includesinstances where the circumstance occurs and instances where it does not.For example, if a device optionally contains a feature for analyzing ablood sample, this means that the analysis feature may or may not bepresent, and, thus, the description includes structures wherein a devicepossesses the analysis feature and structures wherein the analysisfeature is not present.

[0063] “Analyte detecting member” refers to any use, singly or incombination, of chemical test reagents and methods, electrical testcircuits and methods, physical test components and methods, optical testcomponents and methods, and biological test reagents and methods toyield information about a blood sample. Such methods are well known inthe art and may be based on teachings of, e.g. Tietz Textbook ofClinical Chemistry, 3d Ed., Sec. V, pp. 776-78 (Burtis & Ashwood, Eds.,W. B. Saunders Company, Philadelphia, 1999); U.S. Pat. No. 5,997,817 toChrismore et al. (Dec. 7, 1999); U.S. Pat. No. 5,059,394 to Phillips etal. (Oct. 22, 1991); U.S. Pat. No. 5,001,054 to Wagner et al. (Mar. 19,1991); and U.S. Pat. No. 4,392,933 to Nakamura et al. (Jul. 12, 1983),the teachings of which are hereby incorporated by reference, as well asothers. Analyte detecting member may include tests in the sample testchamber that test electrochemical properties of the blood, or they mayinclude optical means for sensing optical properties of the blood (e.g.oxygen saturation level), or they may include biochemical reagents (e.g.antibodies) to sense properties (e.g. presence of antigens) of theblood. The analyte detecting member may comprise biosensing or reagentmaterial that will react with an analyte in blood (e.g. glucose) orother body fluid so that an appropriate signal correlating with thepresence of the analyte is generated and can be read by the readerapparatus. By way of example and not limitation, analyte detectingmember may “associated with”, “mounted within”, or “coupled to” achamber or other structure when the analyte detecting memberparticipates in the function of providing an appropriate signal aboutthe blood sample to the reader device. Analyte detecting member may alsoinclude nanowire analyte detecting members as described herein. Analytedetecting member may use potentiometric, coulometric, or other methoduseful for detection of analyte levels.

[0064] The present invention may be used with a variety of differentpenetrating member drivers. It is contemplated that these penetratingmember drivers may be spring based, solenoid based, magnetic driverbased, nanomuscle based, or based on any other mechanism useful inmoving a penetrating member along a path into tissue. It should be notedthat the present invention is not limited by the type of driver usedwith the penetrating member feed mechanism. One suitable penetratingmember driver for use with the present invention is shown in FIG. 1.This is an embodiment of a solenoid type electromagnetic driver that iscapable of driving an iron core or slug mounted to the penetratingmember assembly using a direct current (DC) power supply. Theelectromagnetic driver includes a driver coil pack that is divided intothree separate coils along the path of the penetrating member, two endcoils and a middle coil. Direct current is alternated to the coils toadvance and retract the penetrating member. Although the driver coilpack is shown with three coils, any suitable number of coils may beused, for example, 4, 5, 6, 7 or more coils may be used.

[0065] Referring to the embodiment of FIG. 1, the stationary ironhousing 10 may contain the driver coil pack with a first coil 12 flankedby iron spacers 14 which concentrate the magnetic flux at the innerdiameter creating magnetic poles. The inner insulating housing 16isolates the penetrating member 18 and iron core 20 from the coils andprovides a smooth, low friction guide surface. The penetrating memberguide 22 further centers the penetrating member 18 and iron core 20. Thepenetrating member 18 is protracted and retracted by alternating thecurrent between the first coil 12, the middle coil, and the third coilto attract the iron core 20. Reversing the coil sequence and attractingthe core and penetrating member back into the housing retracts thepenetrating member. The penetrating member guide 22 also serves as astop for the iron core 20 mounted to the penetrating member 18.

[0066] As discussed above, tissue penetration devices which employspring or cam driving methods have a symmetrical or nearly symmetricalactuation displacement and velocity profiles on the advancement andretraction of the penetrating member as shown in FIGS. 2 and 3. In mostof the available lancet devices, once the launch is initiated, thestored energy determines the velocity profile until the energy isdissipated. Controlling impact, retraction velocity, and dwell time ofthe penetrating member within the tissue can be useful in order toachieve a high success rate while accommodating variations in skinproperties and minimize pain. Advantages can be achieved by taking intoaccount of the fact that tissue dwell time is related to the amount ofskin deformation as the penetrating member tries to puncture the surfaceof the skin and variance in skin deformation from patient to patientbased on skin hydration.

[0067] In this embodiment, the ability to control velocity and depth ofpenetration may be achieved by use of a controllable force driver wherefeedback is an integral part of driver control. Such drivers can controleither metal or polymeric penetrating members or any other type oftissue penetration element. The dynamic control of such a driver isillustrated in FIG. 2C which illustrates an embodiment of a controlleddisplacement profile and FIG. 2D which illustrates an embodiment of athe controlled velocity profile. These are compared to FIGS. 2A and 2B,which illustrate embodiments of displacement and velocity profiles,respectively, of a harmonic spring/mass powered driver. Reduced pain canbe achieved by using impact velocities of greater than about 2 m/s entryof a tissue penetrating element, such as a lancet, into tissue. Othersuitable embodiments of the penetrating member driver are described incommonly assigned, copending U.S. patent application Ser. No.10/127,395, (Attorney Docket No. 38187-2551) filed Apr. 19, 2002 andpreviously incorporated herein.

[0068]FIG. 3 illustrates the operation of a feedback loop using aprocessor 60. The processor 60 stores profiles 62 in non-volatilememory. A user inputs information 64 about the desired circumstances orparameters for a lancing event. The processor 60 selects a driverprofile 62 from a set of alternative driver profiles that have beenpreprogrammed in the processor 60 based on typical or desired tissuepenetration device performance determined through testing at the factoryor as programmed in by the operator. The processor 60 may customize byeither scaling or modifying the profile based on additional user inputinformation 64. Once the processor has chosen and customized theprofile, the processor 60 is ready to modulate the power from the powersupply 66 to the penetrating member driver 68 through an amplifier 70.The processor 60 may measure the location of the penetrating member 72using a position sensing mechanism 74 through an analog to digitalconverter 76 linear encoder or other such transducer. Examples ofposition sensing mechanisms have been described in the embodiments aboveand may be found in the specification for commonly assigned, copendingU.S. patent application Ser. No. 10/127,395, (Attorney Docket No.38187-2551) filed Apr. 19, 2002 and previously incorporated herein. Theprocessor 60 calculates the movement of the penetrating member bycomparing the actual profile of the penetrating member to thepredetermined profile. The processor 60 modulates the power to thepenetrating member driver 68 through a signal generator 78, which maycontrol the amplifier 70 so that the actual velocity profile of thepenetrating member does not exceed the predetermined profile by morethan a preset error limit. The error limit is the accuracy in thecontrol of the penetrating member.

[0069] After the lancing event, the processor 60 can allow the user torank the results of the lancing event. The processor 60 stores theseresults and constructs a database 80 for the individual user. Using thedatabase 79, the processor 60 calculates the profile traits such asdegree of painlessness, success rate, and blood volume for variousprofiles 62 depending on user input information 64 to optimize theprofile to the individual user for subsequent lancing cycles. Theseprofile traits depend on the characteristic phases of penetrating memberadvancement and retraction. The processor 60 uses these calculations tooptimize profiles 62 for each user. In addition to user inputinformation 64, an internal clock allows storage in the database 79 ofinformation such as the time of day to generate a time stamp for thelancing event and the time between lancing events to anticipate theuser's diurnal needs. The database stores information and statistics foreach user and each profile that particular user uses.

[0070] In addition to varying the profiles, the processor 60 can be usedto calculate the appropriate penetrating member diameter and geometrysuitable to realize the blood volume required by the user. For example,if the user requires about 1-5 microliter volume of blood, the processor60 may select a 200 micron diameter penetrating member to achieve theseresults. For each class of lancet, both diameter and lancet tipgeometry, is stored in the processor 60 to correspond with upper andlower limits of attainable blood volume based on the predetermineddisplacement and velocity profiles.

[0071] The lancing device is capable of prompting the user forinformation at the beginning and the end of the lancing event to moreadequately suit the user. The goal is to either change to a differentprofile or modify an existing profile. Once the profile is set, theforce driving the penetrating member is varied during advancement andretraction to follow the profile. The method of lancing using thelancing device comprises selecting a profile, lancing according to theselected profile, determining lancing profile traits for eachcharacteristic phase of the lancing cycle, and optimizing profile traitsfor subsequent lancing events.

[0072]FIG. 4 illustrates an embodiment of a tissue penetration device,more specifically, a lancing device 80 that includes a controllabledriver 179 coupled to a tissue penetration element. The lancing device80 has a proximal end 81 and a distal end 82. At the distal end 82 isthe tissue penetration element in the form of a penetrating member 83,which is coupled to an elongate coupler shaft 84 by a drive coupler 85.The elongate coupler shaft 84 has a proximal end 86 and a distal end 87.A driver coil pack 88 is disposed about the elongate coupler shaft 84proximal of the penetrating member 83. A position sensor 91 is disposedabout a proximal portion 92 of the elongate coupler shaft 84 and anelectrical conductor 94 electrically couples a processor 93 to theposition sensor 91. The elongate coupler shaft 84 driven by the drivercoil pack 88 controlled by the position sensor 91 and processor 93 formthe controllable driver, specifically, a controllable electromagneticdriver.

[0073] Referring to FIG. 5, the lancing device 80 can be seen in moredetail, in partial longitudinal section. The penetrating member 83 has aproximal end 95 and a distal end 96 with a sharpened point at the distalend 96 of the penetrating member 83 and a drive head 98 disposed at theproximal end 95 of the penetrating member 83. A penetrating member shaft201 is disposed between the drive head 98 and the sharpened point 97.The penetrating member shaft 201 may be comprised of stainless steel, orany other suitable material or alloy and have a transverse dimension ofabout 0.1 to about 0.4 mm. The penetrating member shaft may have alength of about 3 mm to about 50 mm, specifically, about 15 mm to about20 mm. The drive head 98 of the penetrating member 83 is an enlargedportion having a transverse dimension greater than a transversedimension of the penetrating member shaft 201 distal of the drive head98. This configuration allows the drive head 98 to be mechanicallycaptured by the drive coupler 85. The drive head 98 may have atransverse dimension of about 0.5 to about 2 mm.

[0074] A magnetic member 102 is secured to the elongate coupler shaft 84proximal of the drive coupler 85 on a distal portion 203 of the elongatecoupler shaft 84. The magnetic member 102 is a substantially cylindricalpiece of magnetic material having an axial lumen 204 extending thelength of the magnetic member 102. The magnetic member 102 has an outertransverse dimension that allows the magnetic member 102 to slide easilywithin an axial lumen 105 of a low friction, possibly lubricious,polymer guide tube 105′ disposed within the driver coil pack 88. Themagnetic member 102 may have an outer transverse dimension of about 1.0to about 5.0 mm, specifically, about 2.3 to about 2.5 mm. The magneticmember 102 may have a length of about 3.0 to about 5.0 mm, specifically,about 4.7 to about 4.9 mm. The magnetic member 102 can be made from avariety of magnetic materials including ferrous metals such as ferroussteel, iron, ferrite, or the like. The magnetic member 102 may besecured to the distal portion 203 of the elongate coupler shaft 84 by avariety of methods including adhesive or epoxy bonding, welding,crimping or any other suitable method.

[0075] Proximal of the magnetic member 102, an optical encoder flag 206is secured to the elongate coupler shaft 84. The optical encoder flag206 is configured to move within a slot 107 in the position sensor 91.The slot 107 of the position sensor 91 is formed between a first bodyportion 108 and a second body portion 109 of the position sensor 91. Theslot 107 may have separation width of about 1.5 to about 2.0 mm. Theoptical encoder flag 206 can have a length of about 14 to about 18 mm, awidth of about 3 to about 5 mm and a thickness of about 0.04 to about0.06 mm.

[0076] The optical encoder flag 206 interacts with various optical beamsgenerated by LEDs disposed on or in the position sensor body portions108 and 109 in a predetermined manner. The interaction of the opticalbeams generated by the LEDs of the position sensor 91 generates a signalthat indicates the longitudinal position of the optical flag 206relative to the position sensor 91 with a substantially high degree ofresolution. The resolution of the position sensor 91 may be about 200 toabout 400 cycles per inch, specifically, about 350 to about 370 cyclesper inch. The position sensor 91 may have a speed response time(position/time resolution) of 0 to about 120,000 Hz, where one dark andlight stripe of the flag constitutes one Hertz, or cycle per second. Theposition of the optical encoder flag 206 relative to the magnetic member102, driver coil pack 88 and position sensor 91 is such that the opticalencoder 91 can provide precise positional information about thepenetrating member 83 over the entire length of the penetrating member'spower stroke.

[0077] An optical encoder that is suitable for the position sensor 91 isa linear optical incremental encoder, model HEDS 9200, manufactured byAgilent Technologies. The model HEDS 9200 may have a length of about 20to about 30 mm, a width of about 8 to about 12 mm, and a height of about9 to about 11 mm. Although the position sensor 91 illustrated is alinear optical incremental encoder, other suitable position sensorembodiments could be used, provided they posses the requisite positionalresolution and time response. The HEDS 9200 is a two channel devicewhere the channels are 90 degrees out of phase with each other. Thisresults in a resolution of four times the basic cycle of the flag. Thesequadrature outputs make it possible for the processor to determine thedirection of penetrating member travel. Other suitable position sensorsinclude capacitive encoders, analog reflective sensors, such as thereflective position sensor discussed above, and the like.

[0078] A coupler shaft guide 111 is disposed towards the proximal end 81of the lancing device 80. The guide 111 has a guide lumen 112 disposedin the guide 111 to slidingly accept the proximal portion 92 of theelongate coupler shaft 84. The guide 111 keeps the elongate couplershaft 84 centered horizontally and vertically in the slot 102 of theoptical encoder 91.

[0079] The driver coil pack 88, position sensor 91 and coupler shaftguide 111 are all secured to a base 113. The base 113 is longitudinallycoextensive with the driver coil pack 88, position sensor 91 and couplershaft guide 111. The base 113 can take the form of a rectangular pieceof metal or polymer, or may be a more elaborate housing with recesses,which are configured to accept the various components of the lancingdevice 80.

[0080] As discussed above, the magnetic member 102 is configured toslide within an axial lumen 105 of the driver coil pack 88. The drivercoil pack 88 includes a most distal first coil 114, a second coil 115,which is axially disposed between the first coil 114 and a third coil116, and a proximal-most fourth coil 117. Each of the first coil 114,second coil 115, third coil 116 and fourth coil 117 has an axial lumen.The axial lumens of the first through fourth coils are configured to becoaxial with the axial lumens of the other coils and together form theaxial lumen 105 of the driver coil pack 88 as a whole. Axially adjacenteach of the coils 114-117 is a magnetic disk or washer 118 that augmentscompletion of the magnetic circuit of the coils 114-117 during a lancingcycle of the device 80. The magnetic washers 118 of the embodiment ofFIG. 5 are made of ferrous steel but could be made of any other suitablemagnetic material, such as iron or ferrite. The outer shell 89 of thedriver coil pack 88 is also made of iron or steel to complete themagnetic path around the coils and between the washers 118. The magneticwashers 118 have an outer diameter commensurate with an outer diameterof the driver coil pack 88 of about 4.0 to about 8.0 mm. The magneticwashers 118 have an axial thickness of about 0.05, to about 0.4 mm,specifically, about 0.15 to about 0.25 mm.

[0081] Wrapping or winding an elongate electrical conductor 121 about anaxial lumen until a sufficient number of windings have been achievedforms the coils 114-117. The elongate electrical conductor 121 isgenerally an insulated solid copper wire with a small outer transversedimension of about 0.06 mm to about 0.88 mm, specifically, about 0.3 mmto about 0.5 mm. In one embodiment, 32 gauge copper wire is used for thecoils 114-117. The number of windings for each of the coils 114-117 ofthe driver pack 88 may vary with the size of the coil, but for someembodiments each coil 114-117 may have about 30 to about 80 turns,specifically, about 50 to about 60 turns. Each coil 114-117 can have anaxial length of about 1.0 to about 3.0 mm, specifically, about 1.8 toabout 2.0 mm. Each coil 114-117 can have an outer transverse dimensionor diameter of about 4.0, to about 2.0 mm, specifically, about 9.0 toabout 12.0 mm. The axial lumen 105 can have a transverse dimension ofabout 1.0 to about 3.0 mm.

[0082] It may be advantageous in some driver coil 88 embodiments toreplace one or more of the coils with permanent magnets, which produce amagnetic field similar to that of the coils when the coils areactivated. In particular, it may be desirable in some embodiments toreplace the second coil 115, the third coil 116 or both with permanentmagnets. In addition, it may be advantageous to position a permanentmagnet at or near the proximal end of the coil driver pack in order toprovide fixed magnet zeroing function for the magnetic member (Adamsmagnetic Products 23A0002 flexible magnet material (800) 747-7543).

[0083]FIGS. 20 and 21 show a permanent bar magnet 119 disposed on theproximal end of the driver coil pack 88. As shown in FIG. 5, the barmagnet 119 is arranged so as to have one end disposed adjacent thetravel path of the magnetic member 102 and has a polarity configured soas to attract the magnetic member 102 in a centered position withrespect to the bar magnet 119. Note that the polymer guide tube 105 canbe configured to extend proximally to insulate the inward radial surfaceof the bar magnet 119 from an outer surface of the magnetic member 102.This arrangement allows the magnetic member 119 and thus the elongatecoupler shaft 84 to be attracted to and held in a zero point or restposition without the consumption of electrical energy from the powersupply 125.

[0084] Having a fixed zero or start point for the elongate coupler shaft84 and penetrating member 83 may be useful to properly controlling thedepth of penetration of the penetrating member 83 as well as otherlancing parameters. This can be because some methods of depthpenetration control for a controllable driver measure the accelerationand displacement of the elongate coupler shaft 84 and penetrating member83 from a known start position. If the distance of the penetratingmember tip 96 from the target tissue is known, acceleration anddisplacement of the penetrating member is known and the start positionof the penetrating member is know, the time and position of tissuecontact and depth of penetration can be determined by the processor 93.

[0085] Any number of configurations for a magnetic bar 119 can be usedfor the purposes discussed above. In particular, a second permanent barmagnet (not shown) could be added to the proximal end of the driver coilpack 88 with the magnetic fields of the two bar magnets configured tocomplement each other. In addition, a disc magnet 119′ could be used asillustrated in FIG. 22. Disc magnet 119′ is shown disposed at theproximal end of the driver coiled pack 88 with a polymer non-magneticdisc 119″ disposed between the proximal-most coil 117 and disc magnet119′ and positions disc magnet 119′ away from the proximal end of theproximal-most coil 117. The polymer non-magnetic disc spacer 119″ isused so that the magnetic member 102 can be centered in a zero or startposition slightly proximal of the proximal-most coil 117 of the drivercoil pack 88. This allows the magnetic member to be attracted by theproximal-most coil 117 at the initiation of the lancing cycle instead ofbeing passive in the forward drive portion of the lancing cycle.

[0086] An inner lumen of the polymer non-magnetic disc 119″ can beconfigured to allow the magnetic member 102 to pass axially therethrough while an inner lumen of the disc magnet 119′ can be configuredto allow the elongate coupler shaft 84 to pass through but not largeenough for the magnetic member 102 to pass through. This results in themagnetic member 102 being attracted to the disc magnet 119′ and comingto rest with the proximal surface of the magnetic member 102 against adistal surface of the disc magnet 119′. This arrangement provides for apositive and repeatable stop for the magnetic member, and hence thepenetrating member. A similar configuration could also be used for thebar magnet 119 discussed above.

[0087] Typically, when the electrical current in the coils 114-117 ofthe driver coil pack 88 is off, a magnetic member 102 made of soft ironis attracted to the bar magnet 119 or disc magnet 119′. The magneticfield of the driver coil pack 88 and the bar magnet 119 or disc magnet119′, or any other suitable magnet, can be configured such that when theelectrical current in the coils 114-117 is turned on, the leakagemagnetic field from the coils 114-117 has the same polarity as the barmagnet 119 or disc magnet 119′. This results in a magnetic force thatrepels the magnetic member 102 from the bar magnet 119 or disc magnet119′ and attracts the magnetic member 102 to the activated coils114-117. For this configuration, the bar magnet 119 or disc magnet thusact to facilitate acceleration of the magnetic member 102 as opposed toworking against the acceleration.

[0088] Electrical conductors 122 couple the driver coil pack 88 with theprocessor 93 which can be configured or programmed to control thecurrent flow in the coils 114-117 of the driver coil pack 88 based onposition feedback from the position sensor 91, which is coupled to theprocessor 93 by electrical conductors 94. A power source 125 iselectrically coupled to the processor 93 and provides electrical powerto operate the processor 93 and power the coil driver pack 88. The powersource 125 may be one or more batteries that provide direct currentpower to the 93 processor.

[0089] Referring to FIGS. 29A-29C, a flow diagram is shown thatdescribes the operations performed by the processor 93 in controllingthe penetrating member 83 of the lancing device 80 discussed aboveduring an operating cycle. FIGS. 30-36 illustrate the interaction of thepenetrating member 83 and skin 133 of the patient's finger 134 during anoperation cycle of the penetrating member device 83. The processor 93operates under control of programming steps that are stored in anassociated memory. When the programming steps are executed, theprocessor 93 performs operations as described herein. Thus, theprogramming steps implement the functionality of the operationsdescribed with respect to the flow diagram of FIG. 29. The processor 93can receive the programming steps from a program product stored inrecordable media, including a direct access program product storagedevice such as a hard drive or flash ROM, a removable program productstorage device such as a floppy disk, or in any other manner known tothose of skill in the art. The processor 93 can also download theprogramming steps through a network connection or serial connection.

[0090] In the first operation, represented by the flow diagram boxnumbered 245 in FIG. 6A, the processor 93 initializes values that itstores in memory relating to control of the penetrating member, such asvariables that it uses to keep track of the controllable driver 179during movement. For example, the processor may set a clock value tozero and a penetrating member position value to zero or to some otherinitial value. The processor 93 may also cause power to be removed fromthe coil pack 88 for a period of time, such as for about 10 ms, to allowany residual flux to dissipate from the coils.

[0091] In the initialization operation, the processor 93 also causes thepenetrating member to assume an initial stationary position. When in theinitial stationary position, the penetrating member 83 is typicallyfully retracted such that the magnetic member 102 is positionedsubstantially adjacent the fourth coil 117 of the driver coil pack 88,shown in FIG. 5 above. The processor 93 can move the penetrating member83 to the initial stationary position by pulsing an electrical currentto the fourth coil 117 to thereby attract the magnetic member 102 on thepenetrating member 83 to the fourth coil 117. Alternatively, themagnetic member can be positioned in the initial stationary position byvirtue of a permanent magnet, such as bar magnet 119, disc magnet 119′or any other suitable magnet as discussed above with regard to thetissue penetration device illustrated in FIGS. 20 and 21.

[0092] In the next operation, represented by the flow diagram boxnumbered 247, the processor 93 energizes one or more of the coils in thecoil pack 88. This should cause the penetrating member 83 to begin tomove (i.e., achieve a non-zero speed) toward the skin target 133. Theprocessor 93 then determines whether or not the penetrating member isindeed moving, as represented by the decision box numbered 149. Theprocessor 93 can determine whether the penetrating member 83 is movingby monitoring the position of the penetrating member 83 to determinewhether the position changes over time. The processor 93 can monitor theposition of the penetrating member 83 by keeping track of the positionof the optical encoder flag 106 secured to the elongate coupler shaft 84wherein the encoder 91 produces a signal coupled to the processor 93that indicates the spatial position of the penetrating member 83.

[0093] If the processor 93 determines (via timeout without motionevents) that the penetrating member 83 is not moving (a “No” result fromthe decision box 149), then the process proceeds to the operationrepresented by the flow diagram box numbered 153, where the processordeems that an error condition is present. This means that some error inthe system is causing the penetrating member 83 not to move. The errormay be mechanical, electrical, or software related. For example, thepenetrating member 83 may be stuck in the stationary position becausesomething is impeding its movement.

[0094] If the processor 93 determines that the penetrating member 83 isindeed moving (a “Yes” result from the decision box numbered 249), thenthe process proceeds to the operation represented by the flow diagrambox numbered 257. In this operation, the processor 93 causes thepenetrating member 83 to continue to accelerate and launch toward theskin target 133, as indicated by the arrow 135 in FIG. 7. The processor93 can achieve acceleration of the penetrating member 83 by sending anelectrical current to an appropriate coil 114-117 such that the coil114-117 exerts an attractive magnetic launching force on the magneticmember 102 and causes the magnetic member 102 and the penetrating member83 coupled thereto to move in a desired direction. For example, theprocessor 93 can cause an electrical current to be sent to the thirdcoil 116 so that the third coil 116 attracts the magnetic member 102 andcauses the magnetic member 102 to move from a position adjacent thefourth coil 117 toward the third coil 116. The processor preferablydetermines which coil 114-117 should be used to attract the magneticmember 102 based on the position of the magnetic member 102 relative tothe coils 114-117. In this manner, the processor 93 provides acontrolled force to the penetrating member that controls the movement ofthe penetrating member.

[0095] During this operation, the processor 93 periodically orcontinually monitors the position and/or velocity of the penetratingmember 83. In keeping track of the velocity and position of thepenetrating member 83 as the penetrating member 83 moves towards thepatient's skin 133 or other tissue, the processor 93 also monitors andadjusts the electrical current to the coils 114-117. In someembodiments, the processor 93 applies current to an appropriate coil114-117 such that the penetrating member 83 continues to move accordingto a desired direction and acceleration. In the instant case, theprocessor 93 applies current to the appropriate coil 114-117 that willcause the penetrating member 83 to continue to move in the direction ofthe patient's skin 133 or other tissue to be penetrated.

[0096] The processor 93 may successively transition the current betweencoils 114-117 so that as the magnetic member 102 moves past a particularcoil 114-117, the processor 93 then shuts off current to that coil114-117 and then applies current to another coil 114-117 that willattract the magnetic member 102 and cause the magnetic member 102 tocontinue to move in the desired direction. In transitioning currentbetween the coils 114-117, the processor 93 can take into accountvarious factors, including the speed of the penetrating member 83, theposition of the penetrating member 83 relative to the coils 114-117, thenumber of coils 114-117, and the level of current to be applied to thecoils 114-117 to achieve a desired speed or acceleration.

[0097] In the next operation, the processor 93 determines whether thecutting or distal end tip 96 of the penetrating member 83 has contactedthe patient's skin 133, as shown in FIG. 8 and as represented by thedecision box numbered 165 in FIG. 6B. The processor 93 may determinewhether the penetrating member 83 has made contact with the targettissue 133 by a variety of methods, including some that rely onparameters which are measured prior to initiation of a lancing cycle andother methods that are adaptable to use during a lancing cycle withoutany predetermined parameters.

[0098] In one embodiment, the processor 93 determines that the skin hasbeen contacted when the end tip 96 of the penetrating member 83 hasmoved a predetermined distance with respect to its initial position. Ifthe distance from the tip 261 of the penetrating member 83 to the targettissue 133 is known prior to initiation of penetrating member 83movement, the initial position of the penetrating member 83 is fixed andknown, and the movement and position of the penetrating member 83 can beaccurately measured during a lancing cycle, then the position and timeof penetrating member contact can be determined.

[0099] This method requires an accurate measurement of the distancebetween the penetrating member tip 96 and the patient's skin 133 whenthe penetrating member 83 is in the zero time or initial position. Thiscan be accomplished in a number of ways. One way is to control all ofthe mechanical parameters that influence the distance from thepenetrating member tip 96 to the patient's tissue or a surface of thelancing device 80 that will contact the patient's skin 133. This couldinclude the start position of the magnetic member 102, magnetic pathtolerance, magnetic member 102 dimensions, driver coil pack 88 locationwithin the lancing device 80 as a whole, length of the elongate couplingshaft 84, placement of the magnetic member 102 on the elongate couplingshaft 84, length of the penetrating member 83 etc.

[0100] If all these parameters, as well as others can be suitablycontrolled in manufacturing with a tolerance stack-up that isacceptable, then the distance from the penetrating member tip 96 to thetarget tissue 133 can be determined at the time of manufacture of thelancing device 80. The distance could then be programmed into the memoryof the processor 93. If an adjustable feature is added to the lancingdevice 80, such as an adjustable length elongate coupling shaft 84, thiscan accommodate variations in all of the parameters noted above, exceptlength of the penetrating member 83. An electronic alternative to thismechanical approach would be to calibrate a stored memory contact pointinto the memory of the processor 93 during manufacture based on themechanical parameters described above.

[0101] In another embodiment, moving the penetrating member tip 96 tothe target tissue 133 very slowly and gently touching the skin 133 priorto actuation can accomplish the distance from the penetrating member tip96 to the tissue 133. The position sensor can accurately measure thedistance from the initialization point to the point of contact, wherethe resistance to advancement of the penetrating member 83 stops thepenetrating member movement. The penetrating member 83 is then retractedto the initialization point having measured the distance to the targettissue 133 without creating any discomfort to the user.

[0102] In another embodiment, the processor 93 may use software todetermine whether the penetrating member 83 has made contact with thepatient's skin 133 by measuring for a sudden reduction in velocity ofthe penetrating member 83 due to friction or resistance imposed on thepenetrating member 83 by the patient's skin 133. The optical encoder 91measures displacement of the penetrating member 83. The position outputdata provides input to the interrupt input of the processor 93. Theprocessor 93 also has a timer capable of measuring the time betweeninterrupts. The distance between interrupts is known for the opticalencoder 91, so the velocity of the penetrating member 83 can becalculated by dividing the distance between interrupts by the timebetween the interrupts.

[0103] This method requires that velocity losses to the penetratingmember 83 and elongate coupler 84 assembly due to friction are known toan acceptable level so that these velocity losses and resultingdeceleration can be accounted for when establishing a decelerationthreshold above which contact between penetrating member tip 96 andtarget tissue 133 will be presumed. This same concept can be implementedin many ways. For example, rather than monitoring the velocity of thepenetrating member 83, if the processor 93 is controlling thepenetrating member driver in order to maintain a fixed velocity, thepower to the driver 88 could be monitored. If an amount of power above apredetermined threshold is required in order to maintain a constantvelocity, then contact between the tip of the penetrating member 96 andthe skin 133 could be presumed.

[0104] In yet another embodiment, the processor 93 determines skin 133contact by the penetrating member 83 by detection of an acoustic signalproduced by the tip 96 of the penetrating member 83 as it strikes thepatient's skin 133. Detection of the acoustic signal can be measured byan acoustic detector 136 placed in contact with the patient's skin 133adjacent a penetrating member penetration site 137, as shown in FIG. 8.Suitable acoustic detectors 136 include piezo electric transducers,microphones and the like. The acoustic detector 136 transmits anelectrical signal generated by the acoustic signal to the processor 93via electrical conductors 138. In another embodiment, contact of thepenetrating member 83 with the patient's skin 133 can be determined bymeasurement of electrical continuity in a circuit that includes thepenetrating member 83, the patient's finger 134 and an electricalcontact pad 240 that is disposed on the patient's skin 133 adjacent thecontact site 137 of the penetrating member 83, as shown in FIG. 8. Inthis embodiment, as soon as the penetrating member 83 contacts thepatient's skin 133, the circuit 139 is completed and current flowsthrough the circuit 139. Completion of the circuit 139 can then bedetected by the processor 93 to confirm skin 133 contact by thepenetrating member 83.

[0105] If the penetrating member 83 has not contacted the target skin133, then the process proceeds to a timeout operation, as represented bythe decision box numbered 167 in FIG. 6B. In the timeout operation, theprocessor 93 waits a predetermined time period. If the timeout periodhas not yet elapsed (a “No” outcome from the decision box 167), then theprocessor continues to monitor whether the penetrating member hascontacted the target skin 133. The processor 93 preferably continues tomonitor the position and speed of the penetrating member 83, as well asthe electrical current to the appropriate coil 114-117 to maintain thedesired penetrating member 83 movement.

[0106] If the timeout period elapses without the penetrating member 83contacting the skin (a “Yes” output from the decision box 167), then itis deemed that the penetrating member 83 will not contact the skin andthe process proceeds to a withdraw phase, where the penetrating memberis withdrawn away from the skin 133, as discussed more fully below. Thepenetrating member 83 may not have contacted the target skin 133 for avariety of reasons, such as if the patient removed the skin 133 from thelancing device or if something obstructed the penetrating member 83prior to it contacting the skin.

[0107] The processor 93 may also proceed to the withdraw phase prior toskin contact for other reasons. For example, at some point afterinitiation of movement of the penetrating member 83, the processor 93may determine that the forward acceleration of the penetrating member 83towards the patient's skin 133 should be stopped or that current to allcoils 114-117 should be shut down. This can occur, for example, if it isdetermined that the penetrating member 83 has achieved sufficientforward velocity, but has not yet contacted the skin 133. In oneembodiment, the average penetration velocity of the penetrating member83 from the point of contact with the skin to the point of maximumpenetration may be about 2.0 to about 10.0 m/s, specifically, about 3.8to about 4.2 m/s. In another embodiment, the average penetrationvelocity of the penetrating member may be from about 2 to about 8 metersper second, specifically, about 2 to about 4 m/s.

[0108] The processor 93 can also proceed to the withdraw phase if it isdetermined that the penetrating member 83 has fully extended to the endof the power stroke of the operation cycle of lancing procedure. Inother words, the process may proceed to withdraw phase when an axialcenter 141 of the magnetic member 102 has moved distal of an axialcenter 142 of the first coil 114 as show in FIG. 5. In this situation,any continued power to any of the coils 114-117 of the driver coil pack88 serves to decelerate the magnetic member 102 and thus the penetratingmember 83. In this regard, the processor 93 considers the length of thepenetrating member 83 (which can be stored in memory) the position ofthe penetrating member 83 relative to the magnetic member 102, as wellas the distance that the penetrating member 83 has traveled.

[0109] With reference again to the decision box 165 in FIG. 6B, if theprocessor 93 determines that the penetrating member 83 has contacted theskin 133 (a “Yes” outcome from the decision box 165), then the processor93 can adjust the speed of the penetrating member 83 or the powerdelivered to the penetrating member 83 for skin penetration to overcomeany frictional forces on the penetrating member 83 in order to maintaina desired penetration velocity of the penetrating member. The flowdiagram box numbered 167 represents this.

[0110] As the velocity of the penetrating member 83 is maintained aftercontact with the skin 133, the distal tip 96 of the penetrating member83 will first begin to depress or tent the contacted skin 137 and theskin 133 adjacent the penetrating member 83 to form a tented portion 243as shown in FIG. 9 and further shown in FIG. 10. As the penetratingmember 83 continues to move in a distal direction or be driven in adistal direction against the patient's skin 133, the penetrating member83 will eventually begin to penetrate the skin 133, as shown in FIG. 11.Once penetration of the skin 133 begins, the static force at the distaltip 96 of the penetrating member 83 from the skin 133 will become adynamic cutting force, which is generally less than the static tipforce. As a result in the reduction of force on the distal tip 96 of thepenetrating member 83 upon initiation of cutting, the tented portion 243of the skin 133 adjacent the distal tip 96 of the penetrating member 83which had been depressed as shown in FIGS. 32 and 24 will spring back asshown in FIG. 11.

[0111] In the next operation, represented by the decision box numbered171 in FIG. 6B, the processor 93 determines whether the distal end 96 ofthe penetrating member 83 has reached a brake depth. The brake depth isthe skin penetration depth for which the processor 93 determines thatdeceleration of the penetrating member 83 is to be initiated in order toachieve a desired final penetration depth 144 of the penetrating member83 as show in FIG. 12. The brake depth may be pre-determined andprogrammed into the processor's memory, or the processor 93 maydynamically determine the brake depth during the actuation. The amountof penetration of the penetrating member 83 in the skin 133 of thepatient may be measured during the operation cycle of the penetratingmember device 80. In addition, as discussed above, the penetration depthsuitable for successfully obtaining a useable sample can depend on theamount of tenting of the skin 133 during the lancing cycle. The amountof tenting of the patient's skin 133 can in turn depend on the tissuecharacteristics of the patient such as elasticity, hydration etc. Amethod for determining these characteristics is discussed below withregard to skin 133 tenting measurements during the lancing cycle andillustrated in FIGS. 37-41.

[0112] Penetration measurement can be carried out by a variety ofmethods that are not dependent on measurement of tenting of thepatient's skin. In one embodiment, the penetration depth of thepenetrating member 83 in the patient's skin 133 is measured bymonitoring the amount of capacitance between the penetrating member 83and the patient's skin 133. In this embodiment, a circuit includes thepenetrating member 83, the patient's finger 134, the processor 93 andelectrical conductors connecting these elements. As the penetratingmember 83 penetrates the patient's skin 133, the greater the amount ofpenetration, the greater the surface contact area between thepenetrating member 83 and the patient's skin 133. As the contact areaincreases, so does the capacitance between the skin 133 and thepenetrating member 83. The increased capacitance can be easily measuredby the processor 93 using methods known in the art and penetration depthcan then be correlated to the amount of capacitance. The same method canbe used by measuring the electrical resistance between the penetratingmember 83 and the patient's skin.

[0113] If the brake depth has not yet been reached, then a “No” resultsfrom the decision box 171 and the process proceeds to the timeoutoperation represented by the flow diagram box numbered 173. In thetimeout operation, the processor 93 waits a predetermined time period.If the timeout period has not yet elapsed (a “No” outcome from thedecision box 173), then the processor continues to monitor whether thebrake depth has been reached. If the timeout period elapses without thepenetrating member 83 achieving the brake depth (a “Yes” output from thedecision box 173), then the processor 93 deems that the penetratingmember 83 will not reach the brake depth and the process proceeds to thewithdraw phase, which is discussed more fully below. This may occur, forexample, if the penetrating member 83 is stuck at a certain depth.

[0114] With reference again to the decision box numbered 171 in FIG. 6B,if the penetrating member does reach the brake depth (a “Yes” result),then the process proceeds to the operation represented by the flowdiagram box numbered 275. In this operation, the processor 93 causes abraking force to be applied to the penetrating member to thereby reducethe speed of the penetrating member 83 to achieve a desired amount offinal skin penetration depth 144, as shown in FIG. 26. Note that FIGS.32 and 33 illustrate the penetrating member making contact with thepatient's skin and deforming or depressing the skin prior to anysubstantial penetration of the skin. The speed of the penetrating member83 is preferably reduced to a value below a desired threshold and isultimately reduced to zero. The processor 93 can reduce the speed of thepenetrating member 83 by causing a current to be sent to a 114-117 coilthat will exert an attractive braking force on the magnetic member 102in a proximal direction away from the patient's tissue or skin 133, asindicated by the arrow 190 in FIG. 13. Such a negative force reduces theforward or distally oriented speed of the penetrating member 83. Theprocessor 93 can determine which coil 114-117 to energize based upon theposition of the magnetic member 102 with respect to the coils 114-117 ofthe driver coil pack 88, as indicated by the position sensor 91.

[0115] In the next operation, the process proceeds to the withdrawphase, as represented by the flow diagram box numbered 177. The withdrawphase begins with the operation represented by the flow diagram boxnumbered 178 in FIG. 6C. Here, the processor 93 allows the penetratingmember 83 to settle at a position of maximum skin penetration 144, asshown in FIG. 12. In this regard, the processor 93 waits until anymotion in the penetrating member 83 (due to vibration from impact andspring energy stored in the skin, etc.) has stopped by monitoringchanges in position of the penetrating member 83. The processor 93preferably waits until several milliseconds (ms), such as on the orderof about 8 ms, have passed with no changes in position of thepenetrating member 83. This is an indication that movement of thepenetrating member 83 has ceased entirely. In some embodiments, thepenetrating member may be allowed to settle for about 1 to about 2000milliseconds, specifically, about 50 to about 200 milliseconds. Forother embodiments, the settling time may be about 1 to about 200milliseconds.

[0116] It is at this stage of the lancing cycle that a software methodcan be used to measure the amount of tenting of the patient's skin 133and thus determine the skin 133 characteristics such as elasticity,hydration and others. Referring to FIGS. 31-41, a penetrating member 83is illustrated in various phases of a lancing cycle with target tissue133. FIG. 14 shows tip 96 of penetrating member 83 making initialcontact with the skin 133 at the point of initial impact.

[0117]FIG. 15 illustrates an enlarged view of the penetrating member 83making initial contact with the tissue 133 shown in FIG. 14. In FIG. 16,the penetrating member tip 96 has depressed or tented the skin 133 priorto penetration over a distance of X, as indicated by the arrow labeled Xin FIG. 16. In FIG. 17, the penetrating member 83 has reached the fulllength of the cutting power stroke and is at maximum displacement. Inthis position, the penetrating member tip 96 has penetrated the tissue133 a distance of Y, as indicated by the arrow labeled Y in FIG. 16. Ascan be seen from comparing FIG. 15 with FIG. 17, the penetrating membertip 96 was displaced a total distance of X plus Y from the time initialcontact with the skin 133 was made to the time the penetrating membertip 96 reached its maximum extension as shown in FIG. 17. However, thepenetrating member tip 96 has only penetrated the skin 133 a distance Ybecause of the tenting phenomenon.

[0118] At the end of the power stroke of the penetrating member 83, asdiscussed above with regard to box 179 of FIG. 6C, the processor 93allows the penetrating member to settle for about 8 msec. It is duringthis settling time that the skin 133 rebounds or relaxes back toapproximately its original configuration prior to contact by thepenetrating member 83 as shown in FIG. 18. The penetrating member tip 96is still buried in the skin to a depth of Y, as shown in FIG. 18,however the elastic recoil of the tissue has displaced the penetratingmember rearward or retrograde to the point of inelastic tenting that isindicated by the arrows Z in FIG. 18. During the rearward displacementof the penetrating member 83 due to the elastic tenting of the tissue133, the processor reads and stores the position data generated by theposition sensor 91 and thus measures the amount of elastic tenting,which is the difference between X and Z.

[0119] Referring to FIG. 19, a tissue penetration sampling device 80 isshown with the controllable driver 179 of FIG. 4 coupled to a samplingmodule cartridge 205 and disposed within a driver housing 206. A ratchetdrive mechanism 207 is secured to the driver housing 206, coupled to thesampling module cartridge 205 and configured to advance a samplingmodule belt 208 within the sampling module cartridge 205 so as to allowsequential use of each sampling module 209 in the sampling module belt208. The ratchet drive mechanism 207 has a drive wheel 211 configured toengage the sampling modules 209 of the sampling module belt 208. Thedrive wheel 211 is coupled to an actuation lever 212 that advances thedrive wheel 211 in increments of the width of a single sampling module209. A T-slot drive coupler 213 is secured to the elongated couplershaft 84.

[0120] A sampling module 209 is loaded and ready for use with the drivehead 98 of the penetrating member 83 of the sampling module 209 loadedin the T-slot 214 of the drive coupler 213. A sampling site 215 isdisposed at the distal end 216 of the sampling module 209 disposed abouta penetrating member exit port 217. The distal end 216 of the samplingmodule 209 is exposed in a module window 218, which is an opening in acartridge cover 221 of the sampling module cartridge 205. This allowsthe distal end 216 of the sampling module 209 loaded for use to beexposed to avoid contamination of the cartridge cover 221 with bloodfrom the lancing process.

[0121] A reader module 222 is disposed over a distal portion of thesampling module 209 that is loaded in the drive coupler 213 for use andhas two contact brushes 224 that are configured to align and makeelectrical contact with analyte detecting member contacts 225 of thesampling module 209 as shown in FIG. 77. With electrical contact betweenthe analyte detecting member contacts 225 and contact brushes 224, theprocessor 93 of the controllable driver 179 can read a signal from ananalytical region 226 of the sampling module 209 after a lancing cycleis complete and a blood sample enters the analytical region 226 of thesampling module 209. The contact brushes 224 can have any suitableconfiguration that will allow the sampling module belt 208 to passlaterally beneath the contact brushes 224 and reliably make electricalcontact with the sampling module 209 loaded in the drive coupler 213 andready for use. A spring loaded conductive ball bearing is one example ofa contact brush 224 that could be used. A resilient conductive stripshaped to press against the inside surface of the flexible polymer sheet227 along the analyte detecting member region 228 of the sampling module209 is another embodiment of a contact brush 224.

[0122] The sampling module cartridge 205 has a supply canister 229 and areceptacle canister 230. The unused sampling modules of the samplingmodule belt 208 are disposed within the supply canister 229 and thesampling modules of the sampling module belt 208 that have been used areadvanced serially after use into the receptacle canister 230.

[0123]FIG. 20 illustrates a further embodiment of sampling modulecartridges. FIG. 20 shows a sampling module cartridge 202 in a carouselconfiguration with adjacent sampling modules 204 connected rigidly andwith analyte detecting members 206 from the analytical regions of thevarious sampling modules 204 disposed near an inner radius 208 of thecarousel. The sampling modules 204 of the sampling module cartridge 202are advanced through a drive coupler 213 but in a circular as opposed toa linear fashion.

[0124]FIG. 21 shows an exploded view in perspective of the cartridge245, which has a proximal end portion 254 and a distal end portion 255.The penetrating member cartridge body 246 is disposed at the proximalend portion 254 of the cartridge 245 and has a plurality of penetratingmember module portions 250, such as the penetrating member moduleportion 250. Each penetrating member module portion 250 has apenetrating member channel 251 with a penetrating member 83 slidablydisposed within the penetrating member channel 251. The penetratingmember channels 251 are substantially parallel to the longitudinal axis252 of the penetrating member cartridge body 246. The penetratingmembers 83 shown have a drive head 98, shaft portion 201 and sharpenedtip 96. The drive head 98 of the penetrating members are configured tocouple to a drive coupler (not shown), such as the drive coupler 85discussed above.

[0125] The penetrating members 83 are free to slide in the respectivepenetrating member channels 251 and are nominally disposed with thesharpened tip 96 withdrawn into the penetrating member channel 251 toprotect the tip 96 and allow relative rotational motion between thepenetrating member cartridge body 246 and the sampling cartridge body247 as shown by arrow 256 and arrow 257 in FIG. 21. The radial center ofeach penetrating member channel 251 is disposed a fixed, known radialdistance from the longitudinal axis 252 of the penetrating membercartridge body 246 and a longitudinal axis 258 of the cartridge 245. Bydisposing each penetrating member channel 251 a fixed known radialdistance from the longitudinal axes 252 and 258 of the penetratingmember cartridge body 246 and cartridge 245, the penetrating memberchannels 251 can then be readily and repeatably aligned in a functionalarrangement with penetrating member channels 253 of the samplingcartridge body 247. The penetrating member cartridge body 246 rotatesabout a removable pivot shaft 259 which has a longitudinal axis 260 thatis coaxial with the longitudinal axes 252 and 250 of the penetratingmember cartridge body 246 and cartridge 245.

[0126] The sampling cartridge body 247 is disposed at the distal endportion 255 of the cartridge and has a plurality of sampling moduleportions 248 disposed radially about the longitudinal axis 249 of thesampling cartridge body 247. The longitudinal axis 249 of the samplingcartridge body 247 is coaxial with the longitudinal axes 252, 258 and260 of the penetrating member cartridge body 246, cartridge 245 andpivot shaft 259. The sampling cartridge body 247 may also rotate aboutthe pivot shaft 259. In order to achieve precise relative motion betweenthe penetrating member cartridge body 246 and the sampling cartridgebody 247, one or both of the cartridge bodies 246 and 247 may berotatable about the pivot shaft 259, however, it is not necessary forboth to be rotatable about the pivot shaft 259, that is, one of thecartridge bodies 246 and 247 may be secured, permanently or removably,to the pivot shaft 259.

[0127] The sampling cartridge body 247 includes a base 261 and a coversheet 262 that covers a proximal surface 263 of the base forming a fluidtight seal. Each sampling module portion 248 of the sampling cartridgebody 247, such as the sampling module portion 248, has a samplereservoir 264 and a penetrating member channel 253. The sample reservoir264 has a vent 965 at an outward radial end that allows the samplereservoir 264 to readily fill with a fluid sample. The sample reservoir264 is in fluid communication with the respective penetrating memberchannel 253 which extends substantially parallel to the longitudinalaxis 249 of the sampling cartridge body 247. The penetrating memberchannel 253 is disposed at the inward radial end of the sample reservoir264. Still further description of the device of FIG. 21 may be found incommonly assigned, copending U.S. patent application Ser. No. 10/127,395(Attorney Docket No. 38187-2551) filed Apr. 19, 2002.

[0128] Referring to FIG. 22A, one embodiment of the present invention isa tissue penetrating system 310 with a plurality of penetrating members312 that each have a tissue penetrating tip 314. The number ofpenetrating members 310 can vary, but numbers in the ranges of 10, 15,25, 50, 75, 100, 500 or any other number, are suitable. Each penetratingmember 312 can be a lancet, a traditional lancet with a molded body, aneedle with a lumen, a knife like element, an elongate member withoutmolded attachments, and the like, and may have a size in the range of 20mm to 10 mm in length and between 0.012-0.040 mm in diameter. It shouldbe understood of course that penetrating members of a variety ofdifferent sizes useful for lancing such as those of conventional lancetsmay be used in other embodiments. As seen in FIG. 22A, the penetratingmember may have an elongate portion with a bend near a proximal end ofthe member.

[0129] Each penetrating member 312 is coupled to a penetrating memberdriver 316. Suitable penetrating member drivers 316 include but are notlimited to, an electric drive force member, a voice coil drive forcegenerator, a linear voice coil device, a rotary voice coil device, andthe like. Suitable drive force generators can be found in commonlyassigned, copending U.S. patent application Ser. No. 10/127,395(Attorney Docket No. 38187-2551) filed Apr. 19, 2002. In one embodiment,the penetrating member driver or drive force generator 316 may be asingle actuator used to advance the penetrating member and to withdrawthe member. The driver 316 may also be used to stop the penetratingmember in the tissue site. Penetrating member driver 316 can be anon-spring actuator for drawing penetrating member 312 in a directionback towards penetrating member driver 316. A coupler 318 on penetratingmember driver 316 is configured to engage at least a portion of anelongate portion of a penetrating member 312 in order to drive thepenetrating member 312 along a path into and through target tissue 320,and then withdrawn from target tissue 320.

[0130] Referring now to FIG. 22B, the tips of the penetrating members312 can be uncovered when they are launched into a selected targettissue 320. In one embodiment, sterility enclosures 322 are provided forcovering at least the tip of each penetrating member 312. FIG. 22B showsthat the enclosure may also cover the entire lancet. In one embodiment,each sterility enclosure 322 is removed from the penetrating member 312prior to actuation, launch, of penetrating member 312 and positioned sothat penetrating member 312 does not contact the associated sterilityenclosure 322 during actuation. As seen in FIG. 22B, the enclosure 322may be peel away to reveal the penetrating member 312 prior to couplingof the member 312 to the drive force generator 316. In anotherembodiment, each penetrating member 312 breaches its associatedsterility enclosure 322 during launch.

[0131] Tissue penetrating system 310 can also include one or morepenetrating member sensors 324 that are coupled to penetrating members312. Examples of suitable penetrating member sensors 324 include but arenot limited to, a capacitive incremental encoder, an incrementalencoder, an optical encoder, an interference encoder, and the like. Eachpenetrating member sensor 324 is configured to provide informationrelative to a depth of penetration of a penetrating member 312 through atarget tissue 320 surface, including but not limited to a skin surface,and the like. The penetrating member sensor 324 may be positioned asshown in FIG. 22B. The penetrating member sensor 324 may also bepositioned in a variety of location such as but not limited to beingcloser to the distal end of the penetrating member, in a position asshown in FIG. 5, or in any other location useful for providing anindication of the position of a penetrating member 312 being driven bythe force generator 316.

[0132] In various embodiments, the penetration depth of a penetratingmember 312 through the surface of a target tissue 320 can be, 100 to2500 microns, 500 to 750 microns, and the like. Each penetrating membersensor 324 can also provide an indication of velocity of a penetratingmember 312. Referring to FIG. 22C, a damper 326 can be coupled topenetrating member driver 316. Damper 326 prevents multiple oscillationsof penetrating member 312 in target tissue 320, particularly afterpenetrating member 312 has reached a desired depth of penetration. Thedamper 326 may be placed in a variety of positions such as but notlimited to being coupled to the penetrating member, being coupled to thecoupler 318, being coupled to a core or shaft in the drive forcegenerator 316, or at any other position useful for slowing the motion ofthe penetrating member 312.

[0133] A feedback loop 328 can also be included that is coupled topenetrating member sensor 324. Each penetrating member 312 sensor can becoupled to a processor 330 that has control instructions for penetratingmember driver 316. By way of illustration, and without limitation,processor 330 can include a memory for storage and retrieval of a set ofpenetrating member 312 profiles utilized with penetrating member driver316. Processor 330 can also be utilized to monitor position and speed ofa penetrating member 312 as it moves in first direction 332 to andthrough the target tissue 320.

[0134] Processor 330 can adjust an application of force to a penetratingmember 312 in order to achieve a desired speed of a penetrating member312. Additionally, processor 330 can also be used to adjust anapplication of force applied to a penetrating member 312 whenpenetrating member 312 contacts target tissue 320 so that penetratingmember 312 penetrates target tissue 320 within a desired range of speed.Further, processor 330 can also monitor position and speed of apenetrating member 312 as penetrating member 312 moves in firstdirection 332 toward the target tissue 320. Application of a launchingforce to penetrating member 312 can be controlled based on position andspeed of penetrating member 312. Processor 330 can control a withdrawforce, from target tissue 320, to penetrating member 312 so thatpenetrating member 312 moves in second direction 334 away from targettissue 320.

[0135] Processor 330 can produce a signal that is indicative of a changein direction and magnitude of force exerted on penetrating member 312.Additionally, processor 330 can cause a braking force to be applied topenetrating member 312.

[0136] In one embodiment, in first direction 332 penetrating member 312moves toward target tissue 320 at a speed that is different than a speedat which penetrating member 312 moves away from target tissue 320 insecond direction 334. In one embodiment, the speed of penetrating member312 in first direction 332 is greater than the speed of penetratingmember 312 in second direction 334. The speed of penetrating member 312in first direction 332 can be a variety of different ranges includingbut not limited to, 0.05 to 60 m/sec, 0.1 to 20.0 m/sec, 1.0 to 10.0m/sec, 3.0 to 8.0 m/sec, and the like. Additionally, the dwell time ofpenetrating member 312 in target tissue 320, below a surface of the skinor other structure, can be in the range of, 1 microsecond to 2 seconds,500 milliseconds to 1.5 second, 100 milliseconds to 1 second, and thelike.

[0137] As seen in FIGS. 22A and 22B, tissue penetrating system 310 caninclude a penetrating member transport device 336 for moving each ofpenetrating member 312 into a position for alignment with penetratingmember driver 316. Penetrating members 312 can be arranged in an arrayconfiguration by a number of different devices and structures definingsupport 338, including but not limited to, a belt, a flexible ornon-flexible tape device, support channel, cog, a plurality ofconnectors, and the like. Support 338 can have a plurality of openingseach receiving a penetrating member 312. Suitable supports 338 may alsoinclude but are not limited to, a bandolier, drum, disc and the like. Adescription of supports 338 can be found in commonly assigned, copendingU.S. patent application Ser. No. 10/127,395 (Attorney Docket No.3818-72551) filed Apr. 19, 2002; commonly assigned, copending U.S.Provisional patent application Ser. No. ______ (Attorney Docket No.38187-PA Feed) filed Dec. 31, 2002; and commonly assigned, copendingU.S. Provisional Patent Application Ser. No. ______ (Attorney Docket No.38187-PA Feed) filed Dec. 31, 2002. All applications listed above arefully incorporated herein by reference for all purposes.

[0138] As illustrated in FIG. 23, tissue penetrating system 310 caninclude a single penetrating member driver 316 and a plurality ofpenetrating members 312. Penetrating member driver 316 moves eachpenetrating member 312 along a path out of a housing that has apenetrating member exit and then into target tissue 320, stopping intarget tissue 320, and then withdrawing out of the target tissue 320.Support 338 couples the penetrating members 312 to define a lineararray. Support 338 is movable and configured to move each penetratingmember 312 to a launch position associated with penetrating memberdriver 316. Penetrating member driver 316 can be controlled to follow apredetermined velocity trajectory into and out of target tissue 320.

[0139] Tissue penetrating system 310 can include a user interface 340configured to relay different information, including but not limited to,skin penetrating performance, a skin penetrating setting, and the like.User interface 340 can provide a user with at a variety of differentoutputs, including but not limited to, penetration depth of apenetrating member 312, velocity of a penetrating member 312, a desiredvelocity profile, a velocity of penetrating member 312 into targettissue 320, velocity of the penetrating member 312 out of target tissue320, dwell time of penetrating member 312 in target tissue 320, a targettissue relaxation parameter, and the like. User interface 340 caninclude a variety of components including but not limited to, a realtime clock 342, one or more alarms 344 to provide a user with a reminderof a next target penetrating event is needed, a user interface processor346, and the like.

[0140] User interface 340 can provide a variety of different outputs toa user including but not limited to, number of penetrating members 312available, number of penetrating members 312 used, actual depth ofpenetrating member 312 penetration on target tissue 320, stratum corneumthickness in the case where the target tissue 320 is the skin and anarea below the skin, force delivered on target tissue 320, energy usedby penetrating member driver 316 to drive penetrating member 312 intotarget tissue 320, dwell time of penetrating member 312, battery statusof tissue penetrating system 310, status of tissue penetrating system310, the amount of energy consumed by tissue penetrating system 310, orany component of tissue penetrating system 310, speed profile ofpenetrating member 312, information relative to contact of penetratingmember 312 with target tissue 320 before penetration by penetratingmember 312, information relative to a change of speed of penetratingmember 312 as in travels in target tissue 320, and the like.

[0141] User interface 340 can include a data interface 348 that couplestissue penetrating system 310 to support equipment 350 with aninterface, the internet, and the like. The data interface 348 may alsobe coupled to the processor 93. Suitable support equipment 350 includesbut is not limited to, a base station, home computer, central server,main processing equipment for storing analyte, such as glucose, levelinformation, and the like.

[0142] Data interface 348 can be a variety of interfaces including butnot limited to, Serial RS-232, modem•interface, USB, HPNA, Ethernet,optical interface, IRDA, RF interface, Bluetooth interface, cellulartelephone interface, two-way pager interface, parallel port interfacestandard, near field magnetic coupling, RF transceiver, telephonesystem, and the like.

[0143] User interface 340 be coupled to a memory 352 that stores, atarget tissue parameter, target tissue 320 penetrating performance, andthe like. The memory 352 may also be connected to processor 93 and storedata from the user interface 340.

[0144] In one embodiment, memory 352 can store, the number of targettissue penetrating events, time and date of the last selected number oftarget tissue penetrating events, time interval between alarm and targettissue penetrating event, stratum corneum thickness, time of day, energyconsumed by penetrating member driver 316 to drive penetrating member312 into target tissue 320, depth of penetrating member 312 penetration,velocity of penetrating member 312, a desired velocity profile, velocityof penetrating member 312 into target tissue 320, velocity ofpenetrating member 312 out of target tissue 320, dwell time ofpenetrating member 312 in target tissue 320, a target tissue relaxationparameter, force delivered on target tissue 320 by any component oftissue penetrating device, dwell time of penetrating member 312, batterystatus of tissue penetrating system 310, tissue penetrating system 310status, consumed energy by tissue penetrating system 310 or any of itscomponents, speed profile of penetrating member 312 as it penetrates andadvances through target tissue 320, a tissue target tissue relaxationparameter, information relative to contact of penetrating member 312with target tissue 320 before penetration by penetrating member 312,information relative to a change of speed of penetrating member 312 asin travels in and through target tissue 320, information relative toconsumed analyte detecting members, and information relative to consumedpenetrating members 312.

[0145] In one embodiment, processor 330 is coupled to and receives anyof a different type of signals from user interface 340. User interface340 can respond to a variety of different commands, including but notlimited to audio commands, and the like. User interface 340 can includea sensor for detecting audio commands. Information can be relayed to auser of tissue penetrating system 310 by way of an audio device,wireless device, and the like.

[0146] In another embodiment as seen in FIG. 23B, tissue penetratingdevice includes a human interface 354 with at least one output. Thehuman interface 354 is specific for use by humans while a user interface340 may be for any type of user, with user defined generically. Humaninterface 354 can be coupled to processor 330 and penetrating membersensor 324. Human interface 354 can be a variety of different varietiesincluding but not limited to, LED, LED digital display, LCD display,sound generator, buzzer, vibrating device, and the like.

[0147] The output of human interface 354 can be a variety of outputsincluding but not limited to, a penetration event by penetrating member312, number of penetrating members 312 remaining, time of day, alarm,penetrating member 312 trajectory waveform profile information, force oflast penetration event, last penetration event, battery status of tissuepenetrating system 310, analyte status, time to change cassette status,jamming malfunction, tissue penetrating system 310 status, and the like.

[0148] Human interface 354 is coupled to a housing 356. Suitablehousings 356 include but are not limited to a, telephone, watch, PDA,electronic device, medical device, point of care device, decentralizeddiagnostic device and the like. An input device 358 is coupled tohousing. Suitable input devices 358 include but are not limited to, oneor more pushbuttons, a touch pad independent of the display device, atouch sensitive screen on a visual display, and the like.

[0149] A data exchange device 360 can be utilized for coupling tissuepenetrating system 310 to support equipment 350 including but notlimited to, personal computer, modem, PDA, computer network, and thelike. Human interface 354 can include a real time clock 362, and one ormore alarms 364 that enable a user to set and use for reminders for thenext target tissue penetration event. Human interface 354 can be coupledto a human interface processor 366 which is distinct from processor 330.Human interface processor 366 can include a sleep mode and can runintermittently to conserve power. Human interface processor 366 includeslogic that can provide an alarm time set for a first subset of days, anda second alarm time set for a second subset of days. By way of example,and without limitation, the first subset of days can be Monday throughFriday, and the second subset of days can be Saturday and Sunday.

[0150] Human interface 354 can be coupled to a memory 368 for storing avariety of information, including but not limited to, the number oftarget tissue penetrating events, time and date of the last selectednumber of target tissue penetrating events, time interval between alarmand target tissue penetrating event, stratum corneum thickness whentarget tissue 320 is below the skin surface and underlying tissue, timeof day, energy consumed by penetrating member driver 316 to drivepenetrating member 312 into target tissue 320, depth of penetratingmember 312 penetration, velocity of penetrating member 312, a desiredvelocity profile, velocity of penetrating member 312 into target tissue320, velocity of penetrating member 312 out of target tissue 320, dwelltime of penetrating member 312 in target tissue 320, a target tissuerelaxation parameter, force delivered on target tissue 320, dwell timeof penetrating member 312, battery status of tissue penetrating system310 and its components, tissue penetrating system 310 status, consumedenergy, speed profile of penetrating member 312 as it advances throughtarget tissue 320, a target tissue relaxation parameter, informationrelative to contact of a penetrating member 312 with target tissue 320before penetration by penetrating member 312, information relative to achange of speed of penetrating member 312 as in travels in target tissue320, information relative to consumed sensors, information relative toconsumed penetrating members 312.

[0151] As illustrated in FIG. 24, tissue penetrating system 310 caninclude a penetrating member driver 316 and a plurality of cartridges370. Each cartridge 370 contains a penetrating member 312. Thecartridges 370 can be coupled together in an array, which can be aflexible array. A cartridge transport device 372 moves cartridges 370into a launch position that operatively couples a penetrating member 312to penetrating member driver 316. A support couples cartridges 370 todefine an array. A plurality of sterility enclosures 322 can be providedto at least cover tips of penetrating members 312. Sterility enclosure322 (shown in phantom) is removed from their associated penetratingmembers 312 prior to launch of the penetrating member 312. The enclosuremay be peeled away (not shown) in a manner similar to that as seen inFIG. 22B, with the enclosure 322 on one tape surface being peeled away.The enclosure 322 may be a blister sack, a sack tightly formed abouteach cartridge 370, or other enclosure useful for maintaining a sterileenvironment about the cartridge 370 prior to actuation or launch. Theenclosure 322 may contain the entire cartridge 370 or some portion ofthe cartridge 370 which may need to remain sterile prior to launch.During launch, enclosure or sterility barrier 322 can be breached by adevice other than penetrating member 312, or can be breached bypenetrating member 312 itself. An analyte detection member, sensor, maybe positioned to receive fluid from a wound created by the penetratingmember 312. The member may be on the cartridge 370 or may be on thedevice 80.

[0152] Referring to FIGS. 24 and 25, one embodiment of tissuepenetrating system 310 includes cartridge transport device 372 and aplurality of cartridges 370. Each cartridge 370 is associated with apenetrating member 312. Cartridge transport device 372 moves eachcartridge 370 to a position to align the associated penetrating member312 with penetrating member driver 316 to drive penetrating member 312along a path into target tissue 320. In one embodiment as seen in FIG.25, each cartridge 370 has at least one of a distal port 374 and aproximal port 376. A first seal 378 is positioned at distal or proximalports. As seen in FIG. 25, the seal 378 may be placed at the distalport. First seal 378 is formed of a material that is fractured bypenetrating member 312 before it is launched. A second seal 380 can bepositioned at the other port. It will be appreciated that only one orboth of distal and proximal ports 374 and 376 can be sealed, and thateach cartridge 370 can include only one port 374 and 376. For ease ofillustration, the penetrating member 312 extending longitudinallythrough the lumen in the cartridge 370 is not shown. The seals 380 and378 may be fracturable seals formed between the penetrating member andthe cartridge 370. During actuation, the seals 378 and 380 are broken.Seal 378 may be also be positioned to cover the distal port or exit port374 without being sealed against the penetrating member (i.e. coveringthe port without touching the penetrating member). A third seal 381 maybe positioned to cover an entrance to sample chamber 384. The seal 381may be configured to be broken when the penetrating member-312 isactuated. A still further seal 381A may be placed in the lumen. The tipof a penetrating member may be located at any position along the lumen,and may also be at or surrounded by one of the seals 378, 381, 381A, or376.

[0153] Referring still to FIG. 25, a cover sheet 383 may be a flexiblepolymer sheet as described in commonly assigned, copending U.S. patentapplication Ser. No. 10/127,395 (Attorney Docket No. 38187-2551) filedApr. 19, 2002. It should be understood of course that the sheet may bemade of a variety of materials useful for coupling an analyte detectingmember 390. This allows the analyte detecting member 390 to besterilized separately from the cartridge 370 and assembled together withthe cartridge at a later time. This process may be used on certainanalyte detecting members 390 that may be damaged if exposed to thesterilization process used on the cartridge 370. Of course, someembodiments may also have the analyte detecting member 390 coupled tothe cartridge 370 during sterilization. The cover sheet 383 may alsoform part of the seal to maintain a sterile environment about portionsof the penetrating member. In other embodiments, the lumen housingpenetrating member may be enclosed and not use a sheet 383 to help forma sterile environment. In still further embodiments, the sheet 383 maybe sized to focus on covering sample chamber 384.

[0154] As illustrated in FIG. 26, cartridge 370 has at least one port374. A plurality of penetrating members 312 are in cartridge 370.Although cartridge 370 is shown in FIG. 26 to have a linear design, thecartridge 370 may also have a curved, round, circular, triangular, orother configuration useful for positioning a penetrating member for usewith a drive force generator. A seal 382 is associated with eachpenetrating member 312 in order to maintain each penetrating member 312in a sterile environment in cartridge 370 prior to launch. Prior tolaunch, seal 382 associated with the penetrating member 312 to belaunched is broken. In one embodiment, a punch (not shown) is used topush down on the seal 382 covering the port 376 of the cartridge 370.This breaks the seal 382 and also pushes it downward, allowing thepenetrating member to exit the cartridge without contacting the seal382. The timing of the breaking of the seal 382 may be varied so long asthe penetrating member remains substantially sterile when being launchedtowards the tissue site 320. In other embodiments, the port 376 may havea seal 383 that protrudes outward and is broken off by the downwardmotion of the punch. One or more sample chambers 384 are included incartridge 370. In one embodiment, each penetrating member 312 has anassociated sample chamber 384. In one embodiment, illustrated in FIG.27, penetrating member 312 is extendable through an opening 386 of itsassociated sample chamber 384. In some embodiments, a seal 387 may beincluded in the sample chamber 384. Seals 382 and 387 may be made from avariety of materials such as but not limited to metallic foil, aluminumfoil, paper, polymeric material, or laminates combining any of theabove. The seals may also be made of a fracturable material. The sealsmay be made of a material that can easily be broken when a deviceapplies a force thereto. The seals alone or in combination with otherbarriers may be used to create a sterile environment about at least thetip of the penetrating member prior to lancing or actuation.

[0155] With reference now to the embodiment of FIG. 28, each samplechamber 384 may have an opening 388 for transport of a body fluid intothe sample chamber 384. The size of sample chambers 384 in FIGS. 26through 28 can vary. In various embodiments, sample chambers 384 aresized to receive, no more than 1.0 mL of the body fluid, no more than0.75 mL of the body fluid, no more than 0.5 mL of the body fluid, nomore than 0.25 mL of the body fluid, no more than 0.1 mL of the bodyfluid, and the like. It will be appreciated that sample chambers 384 canhave larger or smaller sizes.

[0156] An analyte detecting member 390 may associated with each samplechamber 384. The analyte detecting member 390 may be designed for usewith a variety of different sensing techniques as described in commonlyassigned, copending U.S. patent application Ser. No. 10/127,395(Attorney Docket No. 38187-2551) filed Apr. 19, 2002. Analyte detectingmember 390 can be positioned in sample chamber 384, at an exterior ofsample chamber 384, or at other locations useful for obtaining ananalyte. Analyte detecting member 390 can be in a well 392, or merely beplaced on a support.

[0157] In one embodiment, analyte detecting member 390 includeschemistries that are utilized to measure and detect glucose, and otheranalytes. In another embodiment, analyte detecting member 390 isutilized to detect and measure the amount of different analytes in abody fluid or sample. In various embodiments, analyte detecting member390 determines a concentration of an analyte in a body fluid using asample that does not exceed a volume of, 1 mL of a body fluid disposedin sample chamber 384, 0.75 mL of a body fluid disposed in samplechamber 384, 0.5 mL of a body fluid disposed in sample chamber 384, 0.25mL of a body fluid disposed in sample chamber 384, 0.1 mL of a bodyfluid disposed in sample chamber 384, and the like. For example and notby way of limitation, the sample chamber 384 may be of a size largerthan the volumes above, but the analyte detecting member 390 can obtainan analyte reading using the amounts of fluid described above.

[0158] As illustrated in FIG. 29, tissue penetrating system 310 caninclude a housing member 394, a penetrating member 312 positioned inhousing member 394, and analyte detecting member 390 coupled to a samplechamber 384. Analyte detecting member 390 is configured to determine aconcentration of an analyte in a body fluid using with a variety ofdifferent body fluid, sample, volumes. In various embodiments, thevolume is less than 1 mL of body fluid disposed in sample chamber 384,0.75 of body fluid disposed in sample chamber 384, 0.5 of body fluiddisposed in sample chamber 384, 0.25 of body fluid disposed in samplechamber 384, 0.1 of body fluid disposed in sample chamber 384 and thelike. Each tip of a penetrating member 312 is configured to extendthrough an opening of sample chamber 384. A plurality of penetratingmembers 312 can be positioned in housing member 394. Housing member 394can be the same as cartridge 370. Cartridge 370 can have distal andproximal ports 374 and 376, respectively. Additionally, in thisembodiment, a plurality of cartridges 370 can be provided, eachassociated with a penetrating member 312.

[0159] Referring to FIG. 30, each penetrating member 312 has a packingdensity, or occupied volume, in cartridge 370. In various embodiments,the packing density of each penetrating member 312 in cartridge 370 canbe no more than, 5.0 cm3/penetrating member 312, 4.0 cm3/penetratingmember 312, 3.0 cm3/penetrating member 312, 2.0 cm3/penetrating member312, 1.0 cm3/penetrating member 312, 0.75 cm3/penetrating member 312,0.5 cm3/penetrating member 312, 0.25 cm3/penetrating member 312, 0.1cm3/penetrating member 312, and the like. In other words, the volumerequired for each penetrating member does not exceed 5.0 cm3/penetratingmember 312, 4.0 cm3/penetrating member 312, 3.0 cm3/penetrating member312, 2.0 cm3/penetrating member 312, 1.0 cm3/penetrating member 312,0.75 cm3/penetrating member 312, 0.5 cm3/penetrating member 312, 0.25cm3/penetrating member 312, 0.1 cm3/penetrating member 312, and thelike. So, as seen in FIG. 30, if the total package volume of thecartridge is defined as X and the cartridge includes Y number ofpenetrating members 312, penetrating members 312 and test area, or otherunit 395, the volume for each unit does not exceed 5.0 cm3/unit, 4.0cm3/unit, 3.0 cm3/unit, 2.0 cm3/unit, 1.0 cm3/unit, 0.75 cm3/unit, 0.5cm3/unit, 0.25 cm3/unit, 0.1 cm3/unit, and the like.

[0160] In various embodiments, each penetrating member 312 and itsassociated sample chamber 384 have a combined packing density of no morethan about 5.0 cm3, 4.0 cm3, 3.0 cm3, 2.0 cm3, 1.0 cm3, 0.75 cm3, 0.5cm3, 0.25 cm3, 0.1 cm3, and the like.

[0161] With reference, now to FIG. 31, tissue penetrating system 310 canhave a first seal 378 formed at distal port 374 and a second seal 380formed at proximal port 376 of cartridge 370. Prior to launching ofpenetrating member 312, distal seal 378 and second seal 380 maintain adistal tip of penetrating member 312 and sample chamber 384 in a sterileenvironment. Second seal 380 is breached, and penetrating member 312 isthen launched.

[0162] As illustrated in FIG. 32, a plurality of lumens 396 can bepositioned between distal port 374 and proximal port 376 of cartridge370 for slidably receiving a penetrating member 312. Sample chamber 384is defined by cartridge 370, has an opening 398 and is associated withpenetrating member 312. First seal 378 covers distal port 374, and asecond seal 380 covers proximal port 376.

[0163] In another embodiment as shown in FIG. 33, tissue penetratingsystem 310 includes a plurality of cartridges 370, penetrating memberdriver 316, and a plurality of penetrating members 312 coupled topenetrating member driver 316. Each penetrating member 312 is associatedwith a cartridge 370. A plurality of gas-tightly sealed enclosures 400are coupled in an array. Each enclosure 400 fully contains at least oneof cartridge 370. Enclosures 400 are configured to be advanceable oncartridge transport device 372 that individually releases cartridges 370from sacks or enclosures 400 and loads them individually ontopenetrating member driver 316. The enclosures 400 may be removed bypeeling back a top portion of the tape as shown in FIG. 22B.

[0164] In another embodiment, a plurality of penetrating members 312each have a sharpened distal tip. A penetrating member driver 316 iscoupled to each penetrating member 312. A plurality of cartridges 370are coupled in an array. Each cartridge 370 houses a penetrating member312 and is configured to permit penetrating member driver 316 to engageeach of penetrating members 312 sequentially. Each cartridge 370 has aplurality of seals positioned to provide that the sharpened distal tipsremain in a sterile environment before penetrating target tissue 320.Penetrating members 312 are launched without breaking a seal using thepenetrating member.

[0165] Referring now to FIG. 34, a plurality of cartridges 370 areprovided, each having distal and proximal ports 374 and 376,respectively. A plurality of penetrating members 312 are each associatedwith a cartridge 370. Each penetrating member 312 has a sharpened distaltip and a shaft portion slidably disposed within cartridge 370. As seenin FIG. 34, the cartridges 370 may be coupled together by a connector orflexible support 403. A seal 404 is formed by a fracturable materialbetween the penetrating member 312 and each cartridge 370. Seal 404 ispositioned in at least one of distal or proximal ports 374 and 376,respectively, of cartridge 370. Cartridge transport device 372 moveseach cartridge 370 to a position 405 that aligns penetrating member 312with penetrating member driver 316 so that penetrating member 312 can bedriven along a path into target tissue 320.

[0166] In another embodiment of the present invention as seen in FIG.35, tissue penetrating system 310 includes a housing member 406, theplurality of penetrating members 312 positioned in housing member 406,and a tissue stabilizing member 408, which can also be a pressureapplicator, stimulating member, stimulating vibratory member thatimparts motion to a tissue surface, and the like. Tissue stabilizingmember 408 can be positioned to at least partially surround an impactlocation of the penetrating member 312 on the target tissue 320 site.Tissue stabilizing member 408 can, enhance fluid flow from target tissue320, stretch a target tissue 320 surface, apply a vacuum to targettissue 320, apply a force to target tissue 320 and cause target tissue320 to press in an inward direction relative to housing member 406,apply a stimulation to target tissue 320, and the like. Tissuestabilizing member 408 can have a variety of different configurations.In one embodiment, tissue stabilizer member 408 includes a plurality ofprotrusions 410. In some further embodiments, a vacuum source 412 may beprovided to assist the creation of a low pressure environment in thetissue stabilizing member 408 or along the fluid path to a samplechamber associated with the system 310. In some embodiments, the tissuestabilizing member 408 is mounted on the cartridge 370. In otherembodiments, the member 408 may be mounted on the housing 406. Themember 408 may also be pressed against the tissue site 320 and act as apressure applicator. The member 408 may also be used against a varietyof tissue including but not limited to skin or other body tissue.

[0167] Referring now to FIGS. 36 and 37, a cartridge 370 is shown with apenetrating member 312 creating a wound W in the tissue site 320. InFIG. 36, a movable capillary member 420 is extended towards the wound Was indicated by arrow 422 to gather body fluid being expressed from thewound. The fluid may be drawn to a sample chamber 384 (not shown). InFIG. 37, the wound W is created and then the entire cartridge is movedto the tissue site 320 to gather body fluid from the wound W. In someembodiments, the cartridge 370 moves towards the wound W relative to thehousing 406.

[0168] Tissue penetrating systems 310 of FIGS. 22 through 37, can beutilized in a variety of different applications to detect any number ofdifferent analytes, including but not limited to glucose. The systems310 may be used to measure potassium, other ions, or analytes associatedwith the process of glucose monitoring. The analyte detecting member 390may further be adapted to measure other analytes found in body fluid.

[0169] In a still further embodiment, penetrating member 312 may bemoved and positioned to be in engagement with penetrating member driver316. Penetrating member 312 is in a sterile environment, and prior tolaunch, the sterilizing covering, which can be a seal is removed. Tissuestabilizing member can apply a stimulation to a surface of the targettissue 320 prior to, and during penetration by penetration member.Penetrating member 312 is engaged with penetrating driving member andcontrollably pierces a target tissue 320 site. Penetrating member sensor324 is utilized to control penetration depth and velocity of penetratingmember 312. Penetrating member 312 is stopped at a desired depth below asurface of target tissue 320 in order to reduce or eliminate withoutmultiple oscillations against the surface of target tissue 320. A woundis created, causing blood to flow into sample chamber 384. In variousembodiments, no more than 1 mL of a body fluid is collected in samplechamber 384.

[0170] A number of different preferences, options, embodiment, andfeatures have been given above, and following any one of these mayresults in an embodiment of this invention that is more presentlypreferred than a embodiment in which that particular preference is notfollowed. These preferences, options, embodiment, and features may begenerally independent, and additive; and following more than one ofthese preferences may result in a more presently preferred embodimentthan one in which fewer of the preferences are followed.

[0171] While the invention has been described and illustrated withreference to certain particular embodiments thereof, those skilled inthe art will appreciate that various adaptations, changes,modifications, substitutions, deletions, or additions of procedures andprotocols may be made without departing from the spirit and scope of theinvention. Any of the embodiments of the invention may be modified toinclude any of the features described above or feature incorporated byreference herein. For example, the cartridge of FIG. 26 may be adaptedto include a distal portion with a tissue stabilizing member. Thecartridge of FIG. 26 may be adapted for use with a vacuum device. Thecartridge may include indexing features such as notches on the distalportion or outer radial periphery for those cartridges with a radialconfiguration. The notches will facilitate positioning, among otherthings, and may be used for movement. Other cartridges or tapes hereinmay be modified with notches or tractor holes to facilitate movement.User interfaces, human interfaces, and other interfaces may be added toany of the embodiments of the present invention.

[0172] With any of the above embodiments, the location of thepenetrating member drive device may be varied, relative to thepenetrating members or the cartridge. With any of the above embodiments,the penetrating member tips may be uncovered during actuation (i.e.penetrating members do not pierce the penetrating member enclosure orprotective foil during launch). With any of the above embodiments, thepenetrating members may be a bare penetrating member during launch. Withany of the above embodiments, the penetrating members may be barepenetrating members prior to launch as this may allow for significantlytighter densities of penetrating members. In some embodiments, thepenetrating members may be bent, curved, textured, shaped, or otherwisetreated at a proximal end or area to facilitate handling by an actuator.The penetrating member may be configured to have a notch or groove tofacilitate coupling to a gripper or coupler. The notch or groove may beformed along an elongate portion of the penetrating member. The couplermay be designed to create a frictional only type grip on the penetratingmember.

[0173] With any of the above embodiments, any open cavity housing thepenetrating may be on the bottom or the top of the cartridge, with thegripper on the other side. In some embodiments, sensors may be printedon the top, bottom, or side of the cavities. The front end of thecartridge maybe in contact with a user during lancing. The same drivermay be used for advancing and retraction of the penetrating member. Thepenetrating member may have a diameters and length suitable forobtaining the blood volumes described herein. The penetrating memberdriver may also be in substantially the same plane as the cartridge. Thedriver may use a through hole or other opening to engage a proximal endof a penetrating member to actuate the penetrating member along a pathinto and out of the tissue.

[0174] Any of the features described in this application or anyreference disclosed herein may be adapted for use with any embodiment ofthe present invention. For example, the devices of the present inventionmay also be combined for use with injection penetrating members orneedles as described in commonly assigned, copending U.S. patentapplication Ser. No. 10/127,395 (Attorney Docket No. 38187-2551) filedApr. 19, 2002. A sensor to detect the presence of foil may also beincluded in the lancing apparatus. For example, if a cavity has beenused before, the foil or sterility barrier will be punched. The sensorcan detect if the cavity is fresh or not based on the status of thebarrier. It should be understood that in optional embodiments, thesterility barrier may be designed to pierce a sterility barrier ofthickness that does not dull a tip of the penetrating member. Thelancing apparatus may also use improved drive mechanisms. For example, asolenoid force generator may be improved to try to increase the amountof force the solenoid can generate for a given current. A solenoid foruse with the present invention may have five coils and in the presentembodiment the slug is roughly the size of two coils. One change is toincrease the thickness of the outer metal shell or windings surround thecoils. By increasing the thickness, the flux will also be increased. Theslug may be split; two smaller slugs may also be used and offset by ½ ofa coil pitch. This allows more slugs to be approaching a coil where itcould be accelerated. This creates more events where a slug isapproaching a coil, creating a more efficient system.

[0175] In another optional alternative embodiment, a gripper in theinner end of the protective cavity may hold the penetrating memberduring shipment and after use, eliminating the feature of using thefoil, protective end, or other part to retain the used penetratingmember. Some other advantages of the disclosed embodiments and featuresof additional embodiments include: same mechanism for transferring theused penetrating members to a storage area; a high number of penetratingmembers such as 25, 50, 75, 100, 500, or more penetrating members may beput on a disk or cartridge; molded body about a penetrating memberbecomes unnecessary; manufacturing of multiple penetrating memberdevices is simplified through the use of cartridges; handling ispossible of bare rods metal wires, without any additional structuralfeatures, to actuate them into tissue; maintaining extreme (better than50 micron -lateral- and better than 20 micron vertical) precision inguiding; and storage system for new and used penetrating members, withindividual cavities/slots is provided. The housing of the lancing devicemay also be sized to be ergonomically pleasing. In one embodiment, thedevice has a width of about 56 mm, a length of about 105 mm and athickness of about 15 mm. Additionally, some embodiments of the presentinvention may be used with non-electrical force generators or drivemechanism. For example, the punch device and methods for releasing thepenetrating members from sterile enclosures could be adapted for usewith spring based launchers. The gripper using a frictional coupling mayalso be adapted for use with other drive technologies.

[0176] Still further optional features may be included with the presentinvention. For example, with any of the above embodiments, the locationof the penetrating member drive device may be varied, relative to thepenetrating members or the cartridge. With any of the above embodiments,the penetrating member tips may be uncovered during actuation (i.e.penetrating members do not pierce the penetrating member enclosure orprotective foil during launch). The penetrating members may be a barepenetrating member during launch. The same driver may be used foradvancing and retraction of the penetrating member. Different analytedetecting members detecting different ranges of glucose concentration,different analytes, or the like may be combined for use with eachpenetrating member. Non-potentiometric measurement techniques may alsobe used for analyte detection. For example, direct electron transfer ofglucose oxidase molecules adsorbed onto carbon nanotube powdermicroelectrode may be used to measure glucose levels. In all methods,nanoscopic wire growth can be carried out via chemical vapor deposition(CVD). In all of the embodiments of the invention, preferred nanoscopicwires may be nanotubes. Any method useful for depositing a glucoseoxidase or other analyte detection material on a nanowire or nanotubemay be used with the present invention. Expected variations ordifferences in the results are contemplated in accordance with theobjects and practices of the present invention. It is intended,therefore, that the invention be defined by the scope of the claimswhich follow and that such claims be interpreted as broadly as isreasonable.

What is claimed is:
 1. A skin penetrating system, comprising: a housingmember; a plurality of penetrating members positioned in the housingmember, a tissue stabilizing device coupled to the housing member; and auser interface configured to relay at least one of, skin penetratingperformance or a skin penetrating setting.
 2. The system of claim 1,wherein the user interface is configured to provide a user with at leastone input selected from, depth of a penetrating member penetration,velocity of a penetrating member, a desired velocity profile, a velocityof a penetrating member into the target tissue, velocity of thepenetrating member out of the target tissue, dwell time of thepenetrating member in the target tissue, and a target tissue relaxationparameter.
 3. The system of claim 1, wherein the user interface providesat least one output to the user selected from, number of penetratingmembers available, number of penetrating members used, actual depth ofpenetrating member penetration on a target tissue, stratum corneumthickness, force delivered on a target tissue, energy used by apenetrating member driver to drive a penetrating member into the targettissue, dwell time of the penetrating member, battery status, systemstatus, consumed energy, speed profile of a penetrating member,information relative to contact of a penetrating member with targettissue before penetration by the penetrating member, and informationrelative to a change of speed of a penetrating member as in travels inthe target tissue.
 4. The system of claim 1, further comprising: a datainterface configured to couple the tissue penetrating system to at leastone of, support equipment with a data interface and the internet.
 5. Thesystem of claim 1, wherein the support equipment is selected from atleast one of, a base station, home computer, central server, and mainprocessing equipment for storing glucose level information.
 6. Thesystem of claim 4, wherein the data interface is selected from at leastone of, Serial RS-232, modem•interface, USB, HPNA, Ethernet, opticalinterface, IRDA, RF interface, Bluetooth interface, cellular telephoneinterface, 2 way pager interface, parallel port interface standard, nearfield magnetic coupling, RF transceiver and a telephone systems.
 7. Thesystem of claim 1, wherein the user interface includes a real time clockand one or more alarms to provide a user with a reminder of a nexttarget penetrating event is needed.
 8. The system of claim 1, furthercomprising: a processor coupled to the penetrating member driver andconfigured to receive signals from the user interface.
 9. The system ofclaim 4, wherein the processor is configured to assist in an adjustmentof force applied to the penetrating member driver in response to atarget tissue parameter.
 10. The system of claim 1, further comprising:a user interface processor coupled to the user interface.
 11. The systemof claim 1, further comprising: a memory for storing a target tissueparameter.
 12. The system of claim 1, further comprising: a memory forstoring data on target tissue penetrating performance.
 13. The system ofclaim 1, further comprising: a memory for storing at least one of, anumber of penetrating members used, number of target tissue penetratingevents, time and date of the last selected number of target tissuepenetrating events, time interval between alarm and target tissuepenetrating event, stratum corneum thickness, time of day, energyconsumed by a penetrating member driver to drive a penetrating memberinto the target tissue, depth of penetrating member penetration,velocity of the penetrating member, a desired velocity profile, velocityof the penetrating member into the target tissue, velocity of thepenetrating member out of the target tissue, dwell time of thepenetrating member in the target tissue, a target tissue relaxationparameter, force delivered on the target tissue, dwell time of thepenetrating member, battery status, system status, consumed energy,speed profile of the penetrating member as the penetrating penetratesand advances through the target tissue, a tissue target tissuerelaxation parameter, information relative to contact of a penetratingmember with target tissue before penetration by the penetrating member,information relative to a change of speed of a penetrating member as intravels in the target tissue, information relative to consumed sensorsand information relative to consumed penetrating members.
 14. The systemof claim 1, the user interface responds to audio commands.
 15. Thesystem of claim 64, wherein the user interface includes a sensor fordetecting audio commands.
 16. The system of claim 1, wherein the userinterface relays information to a user via an audio device.
 17. Thesystem of claim 1, wherein the user interface relays information to auser via a wireless device.
 18. The system of claim 1, wherein eachpenetrating member is a bare penetrating member without a penetratingmember body or modeled attachment during launch of the penetratingmember.
 19. The system of claim 1, wherein the tissue stabilizer memberis configured to enhance fluid flow from a target tissue.
 20. The systemof claim 1, wherein the tissue stabilizer member creates a stretching ofa skin surface.
 21. The system of claim 1, wherein the tissue stabilizermember includes a plurality of protrusions.
 22. The system of claim 1,wherein the tissue stabilizer member applies a vacuum to a targettissue.
 23. The system of claim 1, wherein the tissue stabilizer memberis configured to apply a force to a target tissue and cause the targettissue to press in an inward direction relative to the housing member.24. The system of claim 1, wherein the tissue stabilizing device appliesa stimulation to a target tissue.
 25. A tissue penetrating device,comprising: a housing; at least one penetrating member a penetratingmember driver coupled to the at least one penetrating member; a tissuestabilizer member coupled to the housing; and a human interfaceproviding at least one output.
 26. The system of claim 25, furthercomprising: a processor coupled to the penetrating member driver andconfigured to change a direction and magnitude of force exerted on apenetrating member as it penetrates or advances through the targettissue.
 27. The system of claim 25, further comprising: a penetratingmember sensor configured to detect a penetrating member position duringtarget tissue penetration.
 28. The system of claim 25, wherein the atleast one output is selected from, a penetration event of a penetratingmember, number of penetrating members remaining, time of day, alarm,penetrating member trajectory waveform profile information, force forlast penetration event, the last penetration event, how or low batterystatus, analyte status, time to change cassette status, jammingmalfunction, and system status.
 29. The system of claim 25, wherein thehuman interface is selected from an LED, an LED digital display, an LCDdisplay, a sound generator, a buzzer, and a vibrating device.
 30. Thesystem of claim 25, wherein the housing is selected from at least oneof, a telephone, a watch, a PDA, electronic device, medical device,point of care device and a decentralized diagnostic device.
 31. Thesystem of claim 25, further comprising: an input device coupled to thehousing, the input device selected from one or more pushbuttons, a touchpad independent of the display device, or a touch sensitive screen on avisual display.
 32. The system of claim 25, further comprising: a dataexchange device for coupling the tissue penetrating system to supportequipment.
 33. The system of claim 32, further comprising: a datainterface configured to couple the tissue penetrating system to supportequipment with a data interface.
 34. The system of claim 25, furthercomprising: a data exchange device for coupling the tissue penetratingsystem to support equipment selected from one of the following: personalcomputer, modem, PDA and a computer network.
 35. The system of claim 25,wherein the human interface includes a real time clock and one or morealarms a user can set for reminders of when a next target tissuepenetration event is needed.
 36. The system of claim 25, wherein thehuman interface is coupled to receive signals from a human interfaceprocessor separate from a processor coupled to the penetrating memberdriver
 37. The system of claim 36, wherein the human interface processorhas a sleep mode and runs intermittently to conserve power.
 38. Thesystem of claim 25, further comprising: a memory for storing at leastone of, a number of penetrating members used, number of target tissuepenetrating events, time and date of the last selected number of targettissue penetrating events, time interval between alarm and target tissuepenetrating event, stratum corneum thickness, time of day, energyconsumed by a penetrating member driver to drive a penetrating memberinto the target tissue, depth of penetrating member penetration,velocity of the penetrating member, a desired velocity profile, velocityof the penetrating member into the target tissue, velocity of thepenetrating member out of the target tissue, dwell time of thepenetrating member in the target tissue, a target tissue relaxationparameter, force delivered on the target tissue, dwell time of thepenetrating member, battery status, system status, consumed energy,speed profile of the penetrating member as the penetrating penetratesand advances through the target tissue, a tissue target tissuerelaxation parameter, information relative to contact of a penetratingmember with target tissue before penetration by the penetrating member,information relative to a change of speed of a penetrating member as intravels in the target tissue, information relative to consumed sensorsand information relative to consumed penetrating members.
 39. The systemof claim 36, wherein the human interface processor has logic thatprovides an alarm time set for a first subset of days and a second alarmtime set for a second subset of days.
 40. The system of claim 39,wherein the first subset of days is Monday thru Friday and the secondsubset of days is Saturday and Sunday.